Skip to main content
Home > The Daily Extra > Top Story

Chronological Index of : Top Story

 Current Issue
  • TOP STORY: Sunovion to acquire Cynapsus for $624M

    The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) announced after market close Wednesday that it will acquire neurology company Cynapsus Therapeutics Inc. (TSX:CTH; NASDAQ:CYNA) …

    Published on 8/31/2016
  • TOP STORY: FDA approves Sandoz's Enbrel biosimilar

    The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved a BLA for Erelzi etanercept-szzs (GP2015), a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). Erelzi is approved in all indications …

    Published on 8/30/2016
  • TOP STORY: Moderna raises $451.4M, per SEC filing

    mRNA therapeutics company Moderna Therapeutics Inc. (Cambridge, Mass.) has raised $451.4 million towards a planned $600 million venture round, according to an SEC filing from last week. The new financing would bring …

    Published on 8/29/2016
  • TOP STORY: Maraganore replaces Tessier-Lavigne as Agios chairman

    Cancer and Orphan disease company Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said Marc Tessier-Lavigne resigned as its chairman "due to other commitments." John Maraganore, a director who is also CEO of Alnylam …

    Published on 8/26/2016
  • TOP STORY: Denali unveils $130M funding, series of deals

    Denali Therapeutics Inc. (South San Francisco, Calif.) disclosed Thursday that it raised $130 million in a series B round and made five deals to flesh out its pipeline. The company is pursuing neurodegenerative diseases…

    Published on 8/25/2016
  • TOP STORY: Biotechs slide after Clinton's EpiPen comments

    In a statement responding to price increases for EpiPen from Mylan N.V. (NASDAQ:MYL), Hillary Clinton slammed drug companies that "put profits ahead of patients, raising prices without justifying the value behind them.…

    Published on 8/24/2016
  • TOP STORY: Clovis jumps on Priority Review for rucaparib

    Clovis Oncology Inc. (NASDAQ:CLVS) gained $4.93 (27%) to $23.03 on Tuesday after it said FDA accepted and granted Priority Review to an NDA seeking accelerated approval of rucaparib (CO-338) as monotherapy in patients …

    Published on 8/23/2016
  • TOP STORY: Pfizer acquiring Medivation

    Pfizer Inc. (NYSE:PFE) is acquiring Medivation Inc. (NASDAQ:MDVN) for $81.50 per share in cash, or about $14 billion. Medivation had negotiated with multiple parties after it rejected unsolicited bids from Sanofi (…

    Published on 8/22/2016
  • TOP STORY: FDA extends review of Sanofi's iGlarLixi

    Sanofi (Euronext:SAN; NYSE:SNY) said FDA has extended a review of Type II diabetes therapy iGlarLixi, a fixed ratio combination of Adlyxin lixisenatide and Lantus insulin glargine. Sanofi said the therapy's PDUFA date …

    Published on 8/19/2016
  • TOP STORY: Complete response delays Portola's AndexXa

    Portola Pharmaceuticals Inc. (NASDAQ:PTLA) slipped $3.57 (15%) to $20.12 on Thursday after it said FDA issued a complete response letter for AndexXa andexanet alfa, which is under review to reverse the anticoagulant …

    Published on 8/18/2016
  • TOP STORY: Indivior's addiction therapy passes Phase III test

    Indivior plc (LSE:INDV) said both tested regimens of RBP-6000 met the primary endpoint of a Phase III study to treat opioid use disorder. The company said FDA could approve the buprenorphine formulation as early as 4Q17…

    Published on 8/17/2016
  • TOP STORY: Tioma raises $86M for anti-CD47 antibodies

    Immuno-oncology play Tioma Therapeutics Inc. (Brisbane, Calif.) raised $86 million in a series A round co-led by RiverVest Venture Partners, Novo Ventures, Roche Venture Fund and SR One. Tioma also named John Donovan …

    Published on 8/16/2016
  • TOP STORY: FDA, stakeholders highlight details in PDUFA VI

    At a public meeting on PDUFA VI, FDA and stakeholders said the agency must make good on its proposals to recruit, hire and retain qualified scientific and medical personnel in order to successfully implement PDUFA VI's …

    Published on 8/15/2016
  • TOP STORY: CFDA releases manufacturing guidance

    In newly released draft guidance, China FDA said drug manufacturers will need to report to the agency any revisions to their approved manufacturing processes, then conduct studies showing that their new processes do not…

    Published on 8/12/2016
  • TOP STORY: Protagonist raises $90M in bumped-up IPO

    Protagonist Therapeutics Inc. (NASDAQ:PTGX) dipped $0.30 to $11.70 in its first day of trading Thursday after it raised $90 million through the sale of 7.5 million shares at $12 in an IPO. Leerink, Barclays and BMO …

    Published on 8/11/2016
  • TOP STORY: AZ invests $140M in Moderna

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said it invested $140 million in Moderna Therapeutics Inc. (Cambridge, Mass.) via a preferred stock financing, bringing its stake in the mRNA therapeutics company to about 9%. AZ and …

    Published on 8/10/2016
  • TOP STORY: AZ's selumetinib fails in Phase III NSCLC study

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said selumetinib (ARRY-886, AZD6244) plus docetaxel missed the primary endpoint in the Phase III SELECT-1 study to treat K-Ras (KRAS) mutation-positive non-small cell lung cancer. The…

    Published on 8/9/2016
  • TOP STORY: Cleave raises $37M in series B

    Cleave Biosciences Inc. (Burlingame, Calif.) raised $37 million in a series B round. New investors Celgene Corp. (NASDAQ:CELG), Nextech Invest and Arcus Ventures joined existing investors 5AM Ventures, Clarus, New …

    Published on 8/8/2016
  • TOP STORY: Opdivo NSCLC failure opens door for other PD-1s

    The failure of PD-1 inhibitor Opdivo nivolumab in a first-line non-small cell lung cancer trial could afford sponsors of other PD-1 mAbs an opportunity to gain market share despite lagging behind the drugs that …

    Published on 8/5/2016
  • TOP STORY: Juno enters MM deal with MSKCC, Eureka

    Memorial Sloan Kettering Cancer Center and Eureka Therapeutics Inc. (Emeryville, Calif.) granted Juno Therapeutics Inc. (NASDAQ:JUNO) exclusive, worldwide rights to binding domains against three multiple myeloma (MM) …

    Published on 8/4/2016
  • TOP STORY: EMA seeks more payer, patient involvement in adaptive pathway

    In a report released Wednesday, EMA said deeper involvement of payers and patients would likely improve its adaptive licensing pathway. Launched via a pilot program in 2014, the pathway is designed to bring drugs to …

    Published on 8/3/2016
  • TOP STORY: Takeout rumors boost Biogen

    Biogen Inc. (NASDAQ:BIIB) gained $28.28 to $330.11 after media reports said Tuesday that companies including Merck & Co. Inc. (NYSE:MRK) and Allergan plc (NYSE:AGN) have explored Biogen as a potential takeover target.…

    Published on 8/2/2016
  • TOP STORY: Biogen opts in for Ionis' nusinersen on Phase III readout

    Biogen Inc. (NASDAQ:BIIB) exercised its exclusive option to obtain worldwide rights to nusinersen (IONIS-SMNRx) from Ionis Pharmaceuticals Inc. (NASDAQ:IONS). The partners said Monday they would stop the Phase III …

    Published on 8/1/2016
  • TOP STORY: Seres' microbiome therapy misses Phase II endpoint

    Seres Therapeutics Inc. (NASDAQ:MCRB) sank $24.83 (69%) to $10.94 on Friday, shedding nearly $1 billion in market cap, after it said microbiome-based therapy SER-109 missed the primary endpoint in the 89-patient Phase …

    Published on 7/29/2016
  • TOP STORY: CARB-X launched to tackle drug-resistant bacteria

    The public-private partnership Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) launched on Thursday with $70 million in committed first-year R&D funding. The five-year program intends to …

    Published on 7/28/2016

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993