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  • TOP STORY: RegenxBio MPS therapy gets rare pediatric disease designation

    RegenxBio Inc. (NASDAQ:RGNX) said FDA granted rare pediatric disease designation to RGX-111, a gene therapy in preclinical testing to treat mucopolysaccharidosis I (MPS I, Hurler syndrome). The designation is among the …

    Published on 12/30/2015
  • TOP STORY: AbbVie seeks clarity on biosimilar interchangeability

    In a Citizen's Petition, AbbVie Inc. (NYSE:ABBV) asked FDA to require that companies seeking interchangeability status for a biosimilar demonstrate interchangeability with a reference product for each of the reference …

    Published on 12/29/2015
  • TOP STORY: Chimerix crushed on Phase III brincidofovir miss

    Chimerix Inc. (NASDAQ:CMRX) dropped $28.95 (81%) to $6.62 on Monday after brincidofovir (CMX001) missed its primary endpoint in the Phase III SUPPRESS trial. The candidate failed to prevent clinically significant …

    Published on 12/28/2015
  • TOP STORY: Adamas spikes on results of PD study

    Adamas Pharmaceuticals Inc. (NASDAQ:ADMS) gained $13.99 (83%) to $30.85 on Wednesday after it said once-daily 340 mg amantadine HCl (ADS-5102) met the primary endpoint of the Phase III EASE LID study to treat levodopa-…

    Published on 12/23/2015
  • TOP STORY: FDA approves Actelion's Uptravi

    FDA approved Uptravi selexipag from Actelion Ltd. (SIX:ATLN) to treat pulmonary arterial hypertension (PAH). Actelion plans to launch the long-acting prostacyclin (IP) receptor (PGI2; PTGIR) agonist in early January …

    Published on 12/22/2015
  • TOP STORY: Bayer, CRISPR form gene editing JV

    Bayer AG (Xetra:BAYN) and CRISPR Therapeutics AG (Basel, Switzerland) will create a joint venture to develop therapeutics for blood disorders, blindness and congenital heart disease, including systemic in vivo therapies…

    Published on 12/21/2015
  • TOP STORY: FDA approves Keytruda for first-line melanoma

    Merck & Co. Inc. (NYSE:MRK) said FDA approved a label expansion for Keytruda pembrolizumab to include first-line treatment in patients with advanced melanoma. The humanized IgG4 mAb against PD-1 is approved to treat …

    Published on 12/18/2015
  • TOP STORY: AZ takes majority stake in Acerta

    AstraZeneca plc (LSE:AZN; NYSE:AZN) will acquire a 55% stake in Acerta Pharma B.V. (Oss, the Netherlands) for $4 billion, including $2.5 billion cash up front and $1.5 billion upon either the first FDA approval of …

    Published on 12/17/2015
  • TOP STORY: AZ bulks up China operations, respiratory portfolio

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said Wednesday it would build up its presence in China and acquire a global respiratory portfolio from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) for $575 million in cash. AZ's …

    Published on 12/16/2015
  • TOP STORY: Congressional Republicans target generic pricing

    Republicans in the U.S. Senate and House are writing legislation and planning oversight activities intended to address outrage over price increases for generic and off-patent drugs imposed by Turing Pharmaceuticals AG (…

    Published on 12/15/2015
  • TOP STORY: FDA makes peace with Pacira

    FDA and Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) have resolved a dispute over the company's promotion of Exparel bupivacaine, a non-opioid analgesic the agency approved in 2011.In a letter sent to the company Monday, …

    Published on 12/14/2015
  • TOP STORY: Roche's Alecensa gets FDA nod for NSCLC

    FDA granted accelerated approval to Alecensa alectinib from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat advanced non-small cell lung cancer in anaplastic lymphoma kinase (ALK)-positive patients who …

    Published on 12/11/2015
  • TOP STORY: FDA panel to discuss CV benefit of Vytorin, Zetia

    FDA reviewers questioned whether adding Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK) to statin therapy can reduce cardiovascular events in a broad patient population compared to a statin alone, or whether such a …

    Published on 12/10/2015
  • TOP STORY: Genmab describes Darzalex-fueled pipeline

    Genmab A/S (CSE:GEN; OTCBB:GMXAY) hopes to put at least four new candidates into the clinic over the next four years using revenue from newly approved multiple myeloma (MM) drug Darzalex daratumumab. The company also …

    Published on 12/9/2015
  • TOP STORY: FDA approves Alexion's Kanuma for LAL-D

    FDA approved Kanuma sebelipase alfa from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat lysosomal acid lipase deficiency and granted the company a Priority Review voucher under the agency's rare pediatric disease …

    Published on 12/8/2015
  • TOP STORY: bluebird, Global Blood sink on SCD results

    bluebird bio Inc. (NASDAQ:BLUE) sank $31.41 (38%) to $52.25 on Monday and Global Blood Therapeutics Inc. (NASDAQ:GBT) shed $11.74 (26%) to $33.93 after the companies presented data on their sickle cell disease products …

    Published on 12/7/2015
  • TOP STORY: Relypsa gains on acquisition rumors

    Relypsa Inc. (NASDAQ:RLYP) gained $6.82 (31%) to $29.14 on Friday after media reports said multiple buyers were interested in acquiring the company. Among the rumored buyers were Merck & Co. Inc. (NYSE:MRK), Sanofi (…

    Published on 12/4/2015
  • TOP STORY: NAS, co-hosts conclude gene editing summit

    The U.S. National Academy of Sciences and National Academy of Medicine, the U.K.'s Royal Academy and the Chinese Academy of Sciences concluded a three-day summit Thursday on human gene editing. The summit's organizing …

    Published on 12/3/2015
  • TOP STORY: Zafgen's beloranib on full clinical hold after second death

    FDA placed a full clinical hold on studies of beloranib (ZGN-440) from Zafgen Inc. (NASDAQ:ZFGN). The move followed the company's announcement that a second patient receiving beloranib died with pulmonary emboli in the …

    Published on 12/2/2015
  • TOP STORY: Sinopharm affiliate licenses Oramed's insulin capsule

    Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) granted an affiliate of China National Pharmaceutical Group Corp. (Sinopharm) exclusive rights in Greater China to ORMD-0801, its oral capsule formulation of insulin to treat …

    Published on 12/1/2015
  • TOP STORY: NAS to co-host gene editing meeting in D.C.

    The U.S. National Academy of Sciences, the U.K.'s Royal Society and the Chinese Academy of Sciences will host a meeting on Dec. 1-3 in Washington, D.C., to discuss the scientific, ethical and governance issues …

    Published on 11/30/2015
  • TOP STORY: Amgen submits BLA for Humira biosimilar

    Amgen Inc. (NASDAQ:AMGN) said Wednesday it submitted a BLA to FDA for ABP 501, a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).Amgen said the application includes Phase III comparative efficacy …

    Published on 11/25/2015
  • TOP STORY: FDA panel finds Kyndrisa efficacy inconclusive

    Panelists at a meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss Kyndrisa drisapersen from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) generally agreed that the therapy's efficacy…

    Published on 11/24/2015
  • TOP STORY: Pfizer, Allergan advance mega-merger

    Pfizer Inc. (NYSE:PFE) and Allergan plc (NYSE:AGN) agreed to a merger valued at $160 billion, telling both Wall Street and Washington that investors and regulators should look at the strategic merits rather than the tax…

    Published on 11/23/2015
  • TOP STORY: FDA reviewers question efficacy of BioMarin's DMD therapy

    In briefing documents released ahead of a Nov. 24 advisory committee meeting, FDA reviewers expressed doubts that Kyndrisa drisapersen from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) is effective to treat Duchenne …

    Published on 11/20/2015

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