The Latest
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Dive AwardsThe BioPharma Dive Awards of 2018
A busy year brought new therapies, a mega-merger and substantial change to the industry. In the process, several companies and technologies stood out.
Corporate News -
Biogen backs away from AGTC after gene therapy failure
The smaller biotech lost a main revenue source and about half its market cap as one of its candidates proved safe but ineffective in a rare eye disorder.
Clinical Trials -
FDA keeps spotlight on GMP data integrity
New guidance from the FDA is aimed at helping manufacturers stay on the agency's good side when it comes to ensuring data are secure and accurate.
Manufacturing -
Mylan patent win for Lantus copy looks unlikely to speed market entry
A patent appeals board invalidated two patents held by Sanofi on its blockbuster insulin. But ongoing litigation in federal court remains a hurdle Mylan has yet to clear.
Legal -
Lilly bets on AC Immune's tech to target Alzheimer's
The companies' focus will be on small molecules that inhibit aggregation of a protein many believe to be integral in Alzheimer's development.
Drug Discovery -
Dive AwardsDeal of the Year: Takeda buys Shire
The $62 billion takeout is the largest acquisition of a foreign company in Japan's history and would transform Takeda into the ninth largest pharma globally.
Mergers and Acquisitions / Deals -
Kaléo, facing criticism, launches generic overdose treatment at cut price
At $178 for a pack of two, Kaléo's authorized copy of its own Evzio will cost far less than the $4,100 list price it set for the branded version.
Marketing -
Orchard to build gene therapy manufacturing plant in California
The planned investment comes months after Orchard struck a deal with GSK to take over development of the British pharma's gene therapy drugs.
Manufacturing -
J&J's Tremfya beats out Novartis' Cosentyx in psoriasis study
Tremfya's success could boost J&J as both drugmakers jockey to carve out a leading position in the hotly competitive market for psoriasis drugs.
Clinical Trials -
FDA turns down Mallinckrodt application for reformulated oxycodone
The specialty drugmaker offered few details on the Complete Response Letter issued by the regulator — the second Mallinckrodt's received this year.
Regulatory / Compliance -
Dive AwardsDrug Launch of the Year: Amgen and Novartis' Aimovig
Choosing a lower-than-expected price was an unusual, disruptive move, but one that could pay off as Amgen and Novartis fend off rivals.
Marketing -
Bausch bids $200M for Synergy gut drug, eyeing turnaround opportunity
Synergy thought its IBS drug Trulance would find success in a growing market. Two years since approval, the company's filed for bankruptcy and put its assets up for sale.
Mergers and Acquisitions / Deals -
Boehringer plans to cut 300 jobs in France
The reductions are tied to ongoing integration of Boehringer's Merial animal health unit as well as competitive challenges in human health, the Germany drugmaker said.
Corporate News -
Merck taps Roche for Keytruda companion diagnostic
The Swiss pharma will develop a test to identify patients with a biomarker known to make solid tumors vulnerable to the immuno-oncology drug.
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Pfizer to add 100 oncology R&D jobs, cut others amid restructure
While the pharma plans to eliminate 100 positions in South San Francisco, California, Pfizer plans to create a similar number in the San Diego area.
Corporate News -
Dive AwardsInnovation of the Year: RNA-targeting therapies
The arrival of Onpattro and Tegsedi cap decades of progress in the field, which has once again drawn the eye of big pharma.
Clinical Trials -
Biktarvy's success raises doubts about ViiV's 'new era' of HIV treatment
ViiV and majority owner GSK are focused on two-drug regimens, while rival Gilead is betting big on its recently approved triplet Biktarvy.
Marketing -
Merck shakes up C-suite as Schechter departs
Adam Schechter, who has led Merck's human health unit since 2010, will step down by year's end. In his place, Merck will promote two execs from within.
Corporate News -
Roche wins key cancer drug approval, but taking on Merck remains a challenge
Despite Tecentriq's OK in frontline metastatic lung cancer, one Wall Street analyst cut sales forecasts for the drug by billions over the next five years.
Marketing -
Gilead names Roche veteran O'Day as CEO
Daniel O'Day, who has led Roche Pharmaceuticals for the past six years, will be tasked with leading Gilead's push into new therapeutic markets.
Corporate News -
Dive AwardsBiotech of the Year: Spark Therapeutics
The biotech's gene therapy Luxturna, priced at $850,000 per patient, is testing a healthcare system not designed for transformative, one-time treatments.
Marketing -
Axovant drops small molecule development after dementia drug failure
The company will shift its focus to gene therapies after a Phase 2 trial setback for nelotanserin in patients with Lewy body dementia.
Clinical Trials -
Lonza bets on China biotech market with plans for new plant
A crop of emerging Chinese biotechs are pushing into novel drug development, increasing demand for CDMO services in a country long known for its API manufacturing.
Manufacturing -
Brexit 'no deal' could mean 6 months of disruption for pharma
The warning comes as the prime minister postponed a crucial vote on an exit plan that had been set for this week.
Regulatory / Compliance -
J&J's Actelion pays out $360M to resolve kickback claims
The Justice Department claimed the pharma donated to a charity to help pay Medicare patients' copays for its drugs.
Regulatory / Compliance