4:54 PM Feb 23, 2018

Herculean task for DMD

Driven by the delayed reimbursement decision for Europe’s only approved DMD therapy, the patient advocacy group Duchenne UK has brought together seven companies in the space to create a set of...

4:51 PM Feb 23, 2018

Patients as pawns

In an apparent game of chicken between Vertex Pharmaceuticals Inc. and French health authorities over the price of the cystic fibrosis drug Orkambi, patients say the decision to use access to...

3:53 PM Feb 22, 2018

Shooting for the universe

CureVac AG is bringing a new modality to the race for a universal flu vaccine with an mRNA program backed by a grant from the Bill & Melinda Gates Foundation. While the company believes its...

3:04 PM Feb 22, 2018

Molecular mentality

A Science study of gene expression signatures in psychiatric disease patients is the field’s largest transcriptomic readout to date, moving it closer toward molecular characterization of mental...

2:56 PM Feb 22, 2018

Belgian Insights

Belgium has provided Europe with a host of pioneering biotechs, led by CEOs who have demonstrated resilience and stamina in the pursuit of homegrown innovation.

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Latest News

4:47 PM Feb 23, 2018

Exact Sciences down on 1Q18 Cologuard guidance

Exact Sciences Corp. (NASDAQ:EXAS) fell $2.62 to $42.37 Friday after providing first quarter projections...

4:29 PM Feb 23, 2018

Scientists develop antibody-ligand traps for checkpoint inhibitor-resistant cancers

A study showed a bifunctional antibody-ligand trap compound comprised of a checkpoint inhibitor and an...

4:29 PM Feb 23, 2018

HKEX reiterates plans to expand listing eligibility for biotechs

Hong Kong Exchanges and Clearing Ltd. (HKEX) published Friday the second round of its consultation paper...

4:23 PM Feb 23, 2018

Neal, Pallone propose Medicare opioid treatment program bill

Reps. Richard Neal (D-Mass.), ranking member of the House Ways and Means Committee, and Frank Pallone (D-N....

4:15 PM Feb 23, 2018

CHMP backs approval of Mylotarg, Alpivab, Kineret

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg...

2:09 PM Feb 23, 2018

Priority Review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:...

2:06 PM Feb 23, 2018

Darzalex guidance buoys Genmab shares

Genmab A/S (CSE:GEN; Pink:GMXAY) gained DKK13.6 billion ($2.3 billion) in market cap across two days of...

2:04 PM Feb 23, 2018

Japan approves Shionogi's single-dose flu treatment

Shionogi & Co. Ltd. (Tokyo:4507) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved...

12:30 PM Feb 23, 2018

XLH therapy burosumab gains EU approval

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the...

11:53 AM Feb 23, 2018

CDER schedules third workshop for patient advocacy groups

FDA’s Center for Drug Evaluation and Research will hold a public workshop on April 3 on how to engage...

11:18 AM Feb 23, 2018

FDA planning pilot program for innovative trial designs

FDA intends to launch by year end a pilot program for complex innovative designs of clinical trials,...

11:01 AM Feb 23, 2018

Bellicum planning changes to end clinical hold

Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) said FDA has outlined criteria required to lift the agency's...

4:56 PM Feb 22, 2018

SubHealth to review bill on dispensing of injectable opioids

The health subcommittee of the House Energy & Commerce Committee will hold a hearing Feb. 28 to...

4:13 PM Feb 22, 2018

Patient-derived GI cancer organoids predict treatment response

Researchers at The Institute of Cancer Research have developed a living biobank of metastatic...

3:16 PM Feb 22, 2018

NZ government to continue funding for rare diseases

The New Zealand Parliament Associate Minister of Health Julie Anne Genter said that PHARMAC, the...

3:12 PM Feb 22, 2018

Prime says drug spending down in 2017

Prime Therapeutics LLC (Eagan, Minn.) said overall member spending in 2017 dropped 0.2% for commercial...

3:09 PM Feb 22, 2018

FDA regulations down

FDA had a significant slowdown in regulatory actions last year and the fewest guidances in four years,...

3:07 PM Feb 22, 2018

Sangamo, Gilead in cell therapy gene editing deal

Sangamo Therapeutics Inc. (NASDAQ:SGMO) gained $3.20 (14%) to $25.40 on Thursday after partnering with the...

2:56 PM Feb 22, 2018

Apellis reports 18-month data for GA candidate

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) reported 18-month data from the Phase II FILLY trial to treat...

1:59 PM Feb 22, 2018

Court sides with FDA in Sensipar exclusivity case

A federal court sided with FDA in a lawsuit in which Amgen Inc. (NASDAQ:AMGN) alleged that the agency had...

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2:59 PM Feb 16, 2018

Earnings on deck

1:31 PM Feb 16, 2018

Listing single

1:18 PM Feb 16, 2018

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