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Predicant Biosciences Inc.
Headquarters:South San Francisco, CA
Website:N/A
Year Founded:2002
Status:Archived
Historical deals and financings can be found by searching the organization's name in the BCIQ Deals and Financing Modules*.*desktop version only

BioCentury | Jul 15, 2013

Regulation

Coding for utility

New, tougher requirements for obtaining Medicare coverage are increasing the cost and time needed to get laboratory-developed molecular diagnostics onto the market and decreasing the certainty that they will be covered. Empowered by a new...

BioCentury | Jul 01, 2021

Politics, Policy & Law

FDA scheduled Alzheimer’s drug coverage meeting with payers before aducanumab approval

FDA has commissioned Duke-Margolis Center to organize a private roundtable meeting in July with payers and other stakeholders to discuss challenges associated with covering and developing evidence for Alzheimer’s therapies such as aducanumab from Biogen...

BioCentury | May 08, 2021

Politics, Policy & Law

How Biden’s IP waiver complicates BIO’s search for a grand bargain

The Biden administration’s embrace of IP waivers for COVID-19 vaccines sent a shockwave through the U.S. biopharmaceutical industry that is reverberating far beyond the offices of manufacturers of pandemic...

BioCentury | Apr 23, 2021

Management Tracks

Chris Austin on turning the ‘valley of death’ into a green oasis

Chris Austin spent nine years as the founding director of NIH’s National Center for Advancing Translational Sciences trying to figure out how to make the trip though the “valley of death” shorter and less...

BioCentury | Apr 09, 2021

Politics, Policy & Law

BIO 3.0: Reinventing the trade association

BIO is rebooting itself, creating what could be called BIO 3.0, the third reimagination of the organization following the paths charted by Carl Feldbaum, who led it from 1993 to 2005, and Jim Greenwood,...

BioCentury | Mar 27, 2021

Product Development

What it will take to meet CEPI’s 100-day vaccine goal for the next pandemic

As CEPI looks to prepare for the next pandemic, it has set a lofty goal to reduce to 100 days the time from sequencing the pathogen to a regulatory submission of a vaccine. But meeting...

BioCentury | Mar 20, 2021

Emerging Company Profile

Blackfynn: optimizing trial design for neurodegenerative therapies

Blackfynn has pivoted from a data service company to a drug developer that in-licenses clinical assets for neurodegenerative disease, starting with a Phase III-ready program for Parkinson’s. Blackfynn Inc. uses its platform to integrate existing...

BioCentury | Mar 16, 2021

Politics, Policy & Law

FTC’s ‘aggressive’ new approach to pharma merger regulation will include biotech M&A

Under the Biden administration, the U.S. Federal Trade Commission will more aggressively investigate, and may block, proposed mergers of pharmaceutical companies. While mergers of large drug companies will be subject to intensified scrutiny, the commission...

BioCentury | Oct 31, 2020

Regulation

Expanding access to COVID-19 vaccines

As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.  ...

BioCentury | Oct 06, 2020

Politics, Policy & Law

Trump treatment resurfaces compassionate use quandaries

President Donald Trump’s treatment with an investigational drug from Regeneron resurfaces long-standing ethical quandaries involving compassionate use and the allocation of scarce drugs. The REGN-COV2...

BioCentury | Sep 09, 2020

Product Development

Roche’s Anderson wants industry to keep its foot on the gas for infectious disease, post-pandemic: a BioCentury audio interview

There will be no turning back to business as usual for drug developers and regulators after COVID-19, according to Bill Anderson, CEO of Roche Pharmaceuticals. But while he’s optimistic about speeding up timelines and changing...

BioCentury | Aug 04, 2020

Product Development

Warp Speed, decentralized trials & SPACs: a BioCentury podcast

After pledging up to $2.1 billion to a preclinical vaccine from Sanofi and GSK, the U.S. government’s total commitment for COVID-19 vaccine candidates now stands at $8.3 billion across seven vaccines based on four different...

BioCentury | Jun 26, 2020

Product Development

21st century pandemic, prehistoric clinical trials: Guest Commentary

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...

BioCentury | May 21, 2020

Product Development

With AZ deal, Operation Warp Speed takes first step to train guns on coronavirus

Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to...

BioCentury | Sep 27, 2019

Politics, Policy & Law

Trump administration to modernize flu vaccines via government buying power

The U.S. government is laying plans to harness its buying power and applied research capabilities to pull influenza vaccine development and manufacturing into the 21st century. The goals are to enhance protection against seasonal flu,...

BioCentury | Aug 31, 2019

Product Development

Digital tech meets the patient: first movers are bringing digital to biopharma

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...

BioCentury | Jun 14, 2019

Company News

bluebird prices β thalassemia gene therapy, first to put majority of revenues at risk

bluebird bio could be the first company to test an outcomes-based pricing model for a gene therapy where the vast majority of the price is at risk. On Friday, bluebird bio Inc. (NASDAQ:BLUE) announced the...

BioCentury | Jun 05, 2019

Finance

Conflicts over scale, response to foreign threats and espionage against NIH research at Senate hearing

A June 5 Senate Finance Committee hearing saw sparks fly over allegations of spying, with two Republican senators accusing the Chinese government of engaging in large-scale espionage against U.S. taxpayer-funded research, and a Democrat countering...

BioCentury | Mar 09, 2019

Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...

BioCentury | Oct 27, 2018

Politics, Policy & Law

Trump’s divide and conquer Part B plan

While its rollout was timed to provide Republicans with ammunition in the last-minute run to the mid-term elections, the Trump administration’s proposal to revamp Part B drug payments won’t go into effect until 2020, at...

BioCentury | Sep 28, 2018

Financial News

AI diagnostic company IDx raises $33M venture round

AI diagnostic company IDx LLC (Coralville, Iowa) raised $33 million in a venture financing on Sept. 26 led by 8VC, with participation from Optum Ventures, Alpha Edison and Heritage Provider Network. In April, FDA approved...

BioCentury | Sep 01, 2018

Politics, Policy & Law

Back to School 2018: A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...

BioCentury | Jun 12, 2018

Politics & Policy

FDA broadens healthcare economic information safe harbor

In an effort to clear a hurdle to outcomes- and other forms of value-based contracts, and to help payers prepare for new products, FDA Tuesday issued new guidance on healthcare economic information. The guidance creates...

BioCentury | Apr 13, 2018

Clinical News

AI diagnostic software gets FDA approval for diabetic retinopathy

FDA approved IDx-DR, an AI-based software from IDx LLC (Coralville, Iowa), to detect greater than a mild level of diabetic retinopathy in adults with diabetes. The approval, which came via FDA's de novo premarket review...

BioCentury | Apr 11, 2018

Company News

AI diagnostic software gets FDA approval for diabetic retinopathy

FDA approved IDx-DR, an AI-based software from IDx LLC (Coralville, Iowa), to detect greater than a mild level of diabetic retinopathy in adults with diabetes. The approval, which came via FDA's de novo premarket review...

BioCentury | Mar 09, 2018

Clinical News

FDA approves 23andMe's direct-to-consumer test for cancer risk

23andMe Inc. (Mountain View, Calif.) said FDA authorized its direct-to-consumer BRCA1/BRCA2 (Selected Variants) Genetic Health Risk (GHR) Report to provide patients with genetic information on their cancer risk. The approval, which came via FDA's de...

BioCentury | Mar 06, 2018

Company News

FDA approves 23andMe's direct-to-consumer test for cancer risk

23andMe Inc. (Mountain View, Calif.) said FDA authorized its direct-to-consumer BRCA1/BRCA2 (Selected Variants) Genetic Health Risk (GHR) Report to provide patients with genetic information on their cancer risk. The approval, which came via FDA's de...

BioCentury | Feb 17, 2018

Politics, Policy & Law

FDA’s bigger piggy bank

FDA plans to use a proposed record-setting funding boost to invest in projects it believes could lead to fundamental improvements in the way medical products are tested, reviewed and manufactured. The goal is to use...

BioCentury | Feb 16, 2018

Clinical News

FDA approves Banyan's brain trauma blood test

FDA approved the Banyan Brain Trauma Indicator (BTI) from Banyan Biomarkers Inc. (Alachua, Fla.) as an in vitro diagnostic blood test to aid in the evaluation of adults with suspected mild traumatic brain injury (TBI)....

BioCentury | Nov 18, 2017

Regulation

Turning the tide

FDA’s plans to blunt the epidemic of opioid abuse, addiction and overdoses will stretch the boundaries of FDA oversight, creating precedents that could be applied in the future to other drug classes and health problems....

BioCentury | Nov 15, 2017

Politics & Policy

FDA shortens NGS regulatory path

FDA announced new rules to streamline approval of next-generation sequencing (NGS)-based tumor profiling diagnostics. The agency said accredited third-party agencies, including the newly accredited New York State Department of Health (NYSDOH), may recommend in vitro...

BioCentury | Sep 02, 2017

Strategy

Back to School 2017: Breach of contract

Merck & Co. Inc. Chairman and CEO Kenneth Frazier’s resignation in August from a White House advisory council was an act of principle, and a reminder that 30 years ago Merck was one of the...

BioCentury | Jul 07, 2017

Finance

Generalists needed

Following a nearly two-year political overhang on the biotech sector, buysiders believe sentiment once again may be turning positive and starting to catch up with the industry’s positive fundamentals. As evidence, they point to the...

BioCentury | Apr 28, 2017

Finance

Hatching VC incubators

While more VCs have created venture incubators to nurture early concepts into full-fledged start-ups, they are aligned more on the need to incubate than on how best to do it. Indeed, a collection of VCs...

BioCentury | Apr 07, 2017

Finance

Taking notice

Political overhang during the first quarter kept generalists on the sidelines but provided a buying opportunity for life sciences specialists that led the sector to outperform. With “repeal and replace” in the rearview for now...

BioCentury | Mar 31, 2017

Politics, Policy & Law

Balancing act

Scott Gottlieb’s toughest political challenge before and after confirmation as FDA commissioner will not be from a hostile Congress, but rather from White House officials who believe the agency is an impediment to medical progress...

BioCentury | Feb 18, 2017

Politics, Policy & Law

Hurry up and wait at FDA

President Donald Trump has shown more interest in FDA than most recent presidents, prompting speculation in Washington that he plans to rapidly appoint an activist commissioner. Trump fueled the rumors when he told pharma CEOs...

BioCentury | Nov 12, 2016

Politics, Policy & Law

Character counts

Republican control of the Senate and House of Representatives is an unambiguous win for biopharma companies, but it is too early to judge what the election of Donald Trump as president will mean for an...

BioCentury | Oct 17, 2016

Politics, Policy & Law

Pruning REGROW

Senate Republican leaders think FDA is unnecessarily impeding the development of regenerative medicines, and they want to use the 21st Century Cures Act as a vehicle to reduce regulatory requirements to market cell- and tissue-based...

BioCentury | Aug 08, 2016

Regulation

Better Modeling Through PDUFA

During negotiations over PDUFA VI FDA and industry agreed on initiatives to advance the agency's capability to accommodate "model-informed drug development" and novel clinical trial designs, two domains that could dramatically improve the speed and...

BioCentury | Jul 07, 2016

Politics & Policy

AHF delaying Ohio drug pricing initiative

A spokesperson for the AIDS Healthcare Foundation said the group plans to place the Drug Price Relief Act on Ohio's ballot for the November 2017 election. The group had been seeking to put the initiative...

BioCentury | Jun 27, 2016

Politics, Policy & Law

Is that clear?

The pharmaceutical cost transparency law recently enacted in Vermont and similar bills pending in other states are part of a loosely coordinated effort to pressure Congress to impose drug price controls. The bills reflect a...

BioCentury | Mar 14, 2016

Politics, Policy & Law

Value demonstration

Acting Administrator Andy Slavitt is pitting CMS against oncologists, hospitals, the pharmaceutical industry and congressional Republicans with a proposal to conduct a massive, nationwide controlled experiment testing value-based payments for drugs provided through Medicare Part...

BioCentury | Jan 25, 2016

Strategy

Formative years

VCs that spend a large chunk of their time and capital creating companies from scratch are planning to continue regardless of what happens with the financial markets. Although de novo company formation takes a lot...

BioCentury | Jan 18, 2016

Politics, Policy & Law

Compounding prices

Joshua Sharfstein, associate dean at the Johns Hopkins Bloomberg School of Public Health, wants to deploy the FDA to battle companies like Turing Pharmaceuticals AG that have enraged the public by obtaining sole U.S. distribution...

BioCentury | Jan 18, 2016

Strategy

Warp's independence day

Stephen Hansen, Associate Editor New revelations about the breadth of Warp Drive Bio LLC's platform, coupled with the lengthy biotech boom, led the company and partner Sanofi to toss out their 2012 build-to-buy deal in...

BioCentury | Apr 13, 2015

Product Development

HCV race in China

Armed with positive Phase II HCV data, Ascletis Pharmaceuticals Co. Ltd. may be able to leapfrog Gilead Sciences Inc. to market in China even though both companies are now seeking approval to begin Phase III...

BioCentury | Dec 22, 2014

Product Development

Targeting access

The American Society of Clinical Oncology and a group being organized by Medicare contractor Palmetto GBA plan to launch separate initiatives next year that will use registries to collect and disseminate evidence on personalized cancer...

BioCentury | Sep 29, 2014

Clinical News

ForeCYTE Breast Aspirator regulatory update

Atossa said FDA declined to approve the company's 510(k) application for the ForeCYTE Breast Aspirator for use in the collection of nipple aspirate fluid for laboratory cytological testing. According to Atossa, FDA determined that ForeCYTE...

BioCentury | Mar 17, 2014

Company News

Massachusetts Life Sciences Center (MLSC) pharmaceuticals news

The MLSC awarded $1.1 million to four projects in the inaugural round of its International Collaborative Industry Program (ICIP). MLSC launched ICIP last April to fund projects jointly sponsored by a Massachusetts life sciences company...

BioCentury | Jun 04, 2021

Deals

Acquisition of Babich-founded Noria helps Bayer pad radiopharmaceutical pipeline

A deal unveiled Thursday will help Bayer expand its footprint in alpha-emitting targeted radiopharmaceuticals. Bayer AG (Xetra:BAYN) announced it will acquire Noria Therapeutics Inc. and its subsidiary PSMA Therapeutics Inc., which have exclusive worldwide rights...

BioCentury | Apr 01, 2013

Company News

Cytori gene/cell therapy news

The U.S. Court of Appeals for the District of Colombia upheld a 2009 FDA decision that two devices from Cytori will require approval through the PMA pathway rather than a 510(k) application. Cytori was seeking...

BioCentury | Mar 04, 2013

Regulation

Bydureon back story

FDA documents detailing its review of the diabetes drug Bydureon exenatide indicate the agency delayed approval by a year and a half after concluding the drug's sponsor, Amylin Pharmaceuticals Inc. , had intentionally and deceptively withheld...

BioCentury | Jan 28, 2013

Regulation

Debating 'limited use'

FDA is asking the public to consider whether it should supplement the current all-or-nothing approval structure with a system that would couple approval of selected new drugs with measures designed to discourage off-label use. The...

BioCentury | May 21, 2012

Regulation

Vive la similitude

While there always has been contention over the rules of the road for biosimilars, the battle lines have shifted since the Biologics Price Competition and Innovation Act was enacted as part of the Affordable Care...

BioCentury | Apr 09, 2012

Finance

Making a baby-maker

Investors injected $37 million into OvaScience Inc. last week so the fertility company can produce clinical data proving its egg precursor stem cell technology can improve the success rate of in vitro fertilization. The cash...

BioCentury | Aug 08, 2011

Politics, Policy & Law

Patently vulnerable

Molecular diagnostics companies will have to include a machine or transformative step in their patent claims based on the ruling by the Court of Appeals for the Federal Circuit in the Myriad Genetics case. The...

BioCentury | May 26, 2011

Targets & Mechanisms

Extracting PD therapy from coffee

A U.S. team that included researchers from Signum Biosciences Inc. has identified a small molecule in coffee that increased motor function in a mouse model of Parkinson's disease. 1 By blocking disease progression, the compound...

BioCentury | Apr 14, 2011

Strategy

Hedging against academic risk

Investors in early stage companies must often take a leap of faith that the academic research behind a company's strategy is well validated and can be reproduced by independent hands. But according to Atlas Venture...

BioCentury | Feb 28, 2011

Product Development

Curing cancer trials

A study reported this month in the Journal of the American Medical Association challenges the standard practice of removing cancerous lymph nodes from the underarms of women with breast cancer. For patients, its finding represents...

BioCentury | Feb 14, 2011

Company News

California Stem Cell, Lonza sales and marketing update

California Stem Cell launched Lonza's MotorPlate Standard and MotorPlate Mature worldwide for motor neuron function and disease research at $1,000/plate and $1,200/plate, respectively. The 96-well plates are seeded with functional, adherent motor neuron progenitors derived...

BioCentury | Oct 18, 2010

Clinical News

Menaflex collagen meniscus implant regulatory update

FDA said it will rescind marketing clearance for ReGen's Menaflex collagen meniscus implant. In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. FDA released a...

BioCentury | Oct 15, 2010

Company News

FDA to rescind clearance for collagen implant

FDA said it will rescind marketing clearance for Menaflex collagen meniscus implant from ReGen Biologics Inc. (OTCBB:RGBO). In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue...

BioCentury | Jun 07, 2010

Company News

Viscofan, University of South Carolina deal

Viscofan's Viscofan BioEngineering business unit received an exclusive license to commercialize the university's collagen microtubes. Viscofan plans to use the technology in its own R&D programs. Viscofan develops collagen-based materials for cell culture, tissue engineering...

BioCentury | Dec 21, 2009

Regulation

Rowing with One Arm

Industry and a parade of FDA commissioners have talked for years about the need to upgrade the agency's ability to apply modern science to its regulatory actions. If done correctly, this would shorten the time...

BioCentury | Apr 13, 2009

Regulation

Deflating Seroquel

AstraZeneca plc went into last week's FDA advisory committee meeting asking for an expansion of the labeled indication for its Seroquel XR quetiapine that could have allowed it to promote the drug for conditions that...

BioCentury | Jul 07, 2008

Strategy

Firazyr sale

After receiving a not approvable letter from FDA in April for its lead compound, Firazyr icatibant, Jerini AG found itself in a dilemma. With only €17 million in the bank, it would need to raise...

BioCentury | Mar 03, 2008

Politics, Policy & Law

Supreme preemption

The U.S. Supreme Court has taken a great interest in suits that pit FDA's authority against state tort laws when a patient has allegedly been harmed by an FDA-approved product. The court ruled in favor...

BioCentury | Jan 28, 2008

Regulation

The long and short of Entereg

FDA's decision on the NDA for Entereg alvimopan due early next month could provide yet another indicator of the agency's risk tolerance. The decision also will provide insights into the risk evaluation and mitigation strategy...

BioCentury | Jan 21, 2008

Regulation

System reset in 2008

Years of negative publicity over adverse effects of drugs and unrelenting political pressure to minimize risks have reshaped the American regulatory environment, effectively creating new requirements for approval that sponsors and investors ignore at their...

BioCentury | Dec 24, 2007

Strategy

One deal, many MOR antibodies

Back to the Future One deal, many MOR antibodies MorphoSys AG expects its new 10-year deal with Novartis AG to be transformational, providing the antibody technology company with the financial security and strategic flexibility to...

BioCentury | Nov 06, 2006

Regulation

Rethinking the HCV roadmap

The regulatory environment for hepatitis C therapies is approaching an inflection point where decisions about clinical trial design requirements - or the failure to make them - could have a major impact on the development of new...

BioCentury | Sep 06, 2006

Politics & Policy

FDA releases position on naming FOBs

FDA expressed a preference against changing the World Health Organization's international nonproprietary names (INN) system as a means to prevent inappropriate substitution of follow-on biologics (FOBs). Trade organizations including the Pharmaceutical Research and Manufacturers of...

BioCentury | May 01, 2006

Product Development

Does size matter?

FDA last week launched what it hopes will be a lively public discussion on whether extremely sensitive outcomes measures or very large trials can produce efficacy results that are statistically significant but are too clinically...

BioCentury | Jan 10, 2005

Company News

Caliper, Predicant deal

...CALP granted Predicant a non-exclusive license to IP covering microfluidics. Predicant will use the IP with...
...protein analysis technology. Financial terms were not disclosed. Caliper Life Sciences Inc. (CALP), Hopkinton, Mass. Predicant Biosciences Inc....

BioCentury | Nov 22, 2004

Company News

Predicant board of directors update

Predicant Biosciences Inc. , South San Francisco, Calif. Business: Diagnostic Appointed: Richard Bastiani, chairman of ID Biomedical Corp. WIR Staff Diagnostic...

BioCentury | Jun 14, 2004

Politics, Policy & Law

NIH: COI vs. ROI

...review. Outside of one publicized instance, in which FDA had approved a consulting arrangement between Biospect...

BioCentury | Jun 04, 2004

Politics & Policy

FDA completes conflict of interest review

...in 2002 to provide consulting services to biomarker company Biospect (South San Francisco, Calif.), now Predicant...

BioCentury | May 18, 2004

Politics & Policy

House wants FDA conflict of interest review

...clinical proteomics program, was given approval in 2002 to provide consulting services to biomarker company Biospect...
...that the consulting was not permissible because FDA and HHS determined that Biospect (now named Predicant...
...regulates, the committee said. It added that the case "raises the concern of whether the Biospect...

BioCentury | Mar 15, 2004

Finance

'A' for effort

...metabolic; functional genomics U.S. Flagship Ventures; Versant Ventures; Highland Capital Partners; MPM Capital; Atlas Venture Biospect...

BioCentury | Feb 02, 2004

Politics & Policy

Budget proposes end to patent fee diversion

The Bush administration's proposed fiscal year 2005 budget, submitted to Congress on Monday, seeks to end the long-standing practice of diverting user fees from the U.S. Patent and Trademark Office to unrelated federal programs. The...

BioCentury | Nov 17, 2003

Politics, Policy & Law

Infinite innuendo

...current NIH employee" for Infinity, as well as for GenPath Pharmaceuticals Inc. , (Cambridge, Mass.), Biospect...

BioCentury | Oct 27, 2003

Finance

Ebb & Flow

...book running lead managers, and HSBC as the co-book runner. Private rounds Biomarker detection company Biospect...
...hired Deborah Neff, former president of BD Biosciences, as president and CEO and a director. Biospect...

BioCentury | Oct 21, 2003

Financial News

Biospect raises $27 million, hires CEO

...Biomarker company Biospect (South San Francisco, Calif.) raised $27 million in a private round. Investors included...
...Neff most recently was worldwide president of BD Biosciences, a segment of Becton Dickinson (BDX). Biospect...

BioCentury | Jun 23, 2003

Clinical News

Endotoxin Activity Assay regulatory update

The FDA granted final marketing clearance for SDI's EAA severe sepsis risk test. Earlier this year, FDA said the test qualified for marketing clearance under the de novo process, which is a regulatory provision for...

BioCentury | Jun 23, 2003

Politics & Policy

FDA Commissioner vows faster approvals

FDA will soon commit itself to reduce the median approval time for most drugs and biologics by 10%, FDA Commissioner Mark McClellan said Monday. The commitments will go beyond those mandated by the Prescription Drug...

BioCentury | Jun 16, 2003

Regulation

CAFC protects research tools

The U.S. Court of Appeals for the Federal Circuit has clarified the boundaries of the Hatch-Waxman Act that exempts from patent infringement some research intended to support a submission to the FDA. The decision interprets...

BioCentury | Jun 02, 2003

Finance

The QT mandate

The FDA and its clinical advisors have concluded that clinical testing for QT prolongation should be required for all new drugs, even though it's clear that the measure is not a particularly good surrogate for...

BioCentury | May 12, 2003

Finance

Europe's Iceberg II

A growing group of maturing European biotech companies has quietly reached the expensive part of the drug development process, giving the sector the opportunity to create a new generation of product-oriented companies without the baggage...

BioCentury | Apr 07, 2003

Clinical News

Endotoxin Activity Assay regulatory update

The FDA said SDI's EAA severe sepsis risk test qualifies for marketing clearance under the de novo process, which is a regulatory provision for new medical devices. SDI said the test now needs to be...

BioCentury | Dec 09, 2002

Tools & Techniques

States vs. drug prices

Squeezed between declining revenues and expanding numbers of poor and uninsured residents who need medical care, the states have become laboratories for experiments in drug cost containment. As a result they are developing policies that...

BioCentury | Nov 04, 2002

Regulation

CBER sowing worries about an exodus

From senior management to review staff, employees at FDA's Center for Biologics Evaluation and Research are warning that the CBER-CDER reorganization leaves them with the short end of the stick and are suggesting that a...

BioCentury | Jun 10, 2002

Strategy

Bring back medicine

As the winter of discontent has drifted into a silent spring, the discouraging signs are very clear: The pipeline shortage, particularly at big pharma; the failed clinical milestones; the shortfall in the regulatory queue; and...

BioCentury | Mar 18, 2002

Strategy

Looking for signs of erosion

Avonex vs. Rebif Looking for signs of erosion A marketing war between Biogen Inc. and Serono S.A. might expand the market for interferon-beta therapy by increasing interest in the drugs to treat relapsing-remitting multiple sclerosis...

BioCentury | Dec 10, 2001

Regulation

PDUFA countdown

When FDA officials and representatives of the pharmaceutical and biotech industries meet in January to begin serious negotiations on reauthorizing the Prescription Drug User Fee Act, they will have relatively modest goals compared to the...

BioCentury | Sep 18, 2000

Regulation

Debating the next PDUFA

WASHINGTON - FDA Commissioner Jane Henney last week used a public forum on the Prescription Drug User Fee Act (PDUFA) to campaign for increased federal funding for the agency. Congress has flat-lined FDA's budget for several...

BioCentury | Jan 04, 2000

Finance

1999 Financial Markets Review: Out with the old

Mergers and acquisitions finally had a significant impact on the biotech sector last year, as for the first time in the history of the group a meaningful number of public companies disappeared. Those companies are...

BioCentury | Jan 04, 1999

Tools & Techniques

Defining efficacy

When Idec Pharmaceuticals Corp. and partner SmithKline Beecham selected IDEC-151 clenoliximab as their lead anti-CD4 antibody to treat rheumatoid arthritis, the choice was predicated on IDEC-151 being superior to the former antibody (IDEC-CE9.1) in terms...

BioCentury | Sep 21, 1998

Finance

The coming train wreck

The health and happiness of the biotech industry has been predicated on a never-ending flow of private and public monies to finance young, loss-making companies. This equation has encouraged academic scientists and their venture backers...

BioCentury | Nov 18, 1996

Strategy

Clinical practice drives marimastat deal

Clinical practice drives marimastat deal In a move to secure a position in Japan's market for cancer drugs, Tanabe Seiyaku Co. Ltd. (Osaka, Japan) sealed a deal potentially worth $74 million to develop and market...