19:14 , May 20, 2019 |  BC Extra  |  Clinical News

May 20 Clinical Quick Takes: Keytruda misses in TNBC; plus Medicines Co., Acadia, Takeda, Ocular

Keytruda fails in previously treated TNBC  Monotherapy with PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) missed the primary endpoint of improving overall survival vs. physician’s choice of single agent chemotherapy in the...
00:46 , May 11, 2019 |  BioCentury  |  Product Development

Now grown up, independent biotechs bulk up their platforms with more modalities

As the incoming class of independent biotechs look to build on their clinical and commercial successes, a handful are expanding beyond the technology that got them there, bringing in new modalities to complement their platforms...
22:46 , May 6, 2019 |  BC Extra  |  Company News

Pfizer's small molecule tafamidis approved for TTR amyloid cardiomyopathy

FDA approved two forms of Pfizer's tafamidis Monday well ahead of their PDUFA dates, making the therapies the first small molecules approved for the cardiomyopathy dominant form of transthyretin (TTR) amyloidosis in the U.S. The...
23:29 , May 3, 2019 |  BioCentury  |  Product Development

Independents’ day: after their first solo launch, biotechs look to new partnering strategies

Having taken their first products to market alone, the new class of independent biotechs face decisions for what to keep and what to change as they seek to build sustainable value as end-to-end companies. One...
18:21 , May 3, 2019 |  BC Week In Review  |  Company News

Express Scripts excludes rare disease drugs Onpattro, Ingrezza

Express Scripts excluded from its 2019 preferred formulary two rare disease therapy, Alnylam's amyloidosis drug Onpattro patisiran and Neurocrine's tardive dyskinesia drug Ingrezza valbenazine. Each are one of two approved drugs in their respective indications....
00:21 , May 3, 2019 |  BC Innovations  |  Product Development

With a deal and a debut, targeted oligo delivery gets a boost from ADCs

The marriage of antibody-drug conjugates and oligonucleotides won two votes of confidence last month with a deal between Lilly and Avidity, and the debut of Atlas-backed Dyne Therapeutics. The approach promises delivery of oligos to...
21:52 , May 1, 2019 |  BC Extra  |  Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
21:58 , Apr 26, 2019 |  BioCentury  |  Product Development

Rise of the independents, biotechs go to market

While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds...
20:12 , Apr 23, 2019 |  BC Extra  |  Politics & Policy

Biopharma battling drug price regulations in Massachusetts

The Massachusetts House of Representatives is set to vote this week on a bill that would regulate the prices of the highest-cost drugs purchased by the state’s MassHealth Medicaid program. Massachusetts biopharma companies are fighting...
23:08 , Apr 12, 2019 |  BC Extra  |  Clinical News

Alnylam's givosiran reduces mean porphyria attacks by 74% in Phase III

Alnylam reported detailed data Friday showing that givosiran reduced the mean attack rate in acute hepatic porphyria patients by 74% in the Phase III ENVISION trial. The company reaffirmed its plans to complete submission of...