Mirati data to test whether biotech can challenge Amgen in KRAS quest
by Ned Pagliarulo on October 18, 2019 at 3:30 pm
Shares in Mirati soared this year, driven higher by optimism the drugmaker can replicate Amgen’s KRAS success. Data due Oct. 28 will give the first look at whether Mirati’s candidate holds promise.
Merck to lay off 500 US-based employees
by Andrew Dunn on October 18, 2019 at 3:24 pm
Affected employees are on commercial teams and will depart on Jan. 3, 2020, said the drugmaker, which claimed the cuts are not part of a new restructuring.
J&J reels after FDA finds ‘sub-trace’ levels of asbestos in its baby powder
by Eric Sagonowsky on October 18, 2019 at 3:19 pm
Johnson & Johnson’s talc woes deepened Friday after the FDA turned up “sub-trace” levels of asbestos in the company’s baby powder, triggering a recall. J&J only pulled one lot of the product, but amid a high-profile legal fight, spooked investors headed for the exits, wiping billions off the drugmaker’s market value.
Teva recalls tainted Zantac generics in the U.K.
by Eric Palmer on October 18, 2019 at 2:26 pm
Another major drugmaker is recalling its Zantac generics because of the possibility they contain unsafe levels of a possible carcinogen. Teva, which does not sell ranitidine products in the U.S., has recalled 10 batches of the drugs in the U.K.
Pfizer’s Vyndaqel franchise, buoyed by diagnoses, is poised for ‘a decisive beat’: analyst
by Angus Liu on October 18, 2019 at 2:15 pm
Pfizer’s tafamidis franchise has been on a road paved with blockbuster hopes since its FDA nod in May. Now, one group of analysts says the drug’s early uptake has been faster than expected—and physicians tend to favor it over rivals by Alnylam and Ionis.
Merck to lay off 500 workers around the U.S. in continued shift to innovative meds
by Eric Sagonowsky on October 18, 2019 at 2:06 pm
Merck has struggled with certain diabetes and cardiovascular drugs, but its cancer business—including star checkpoint inhibitor Keytruda—is booming. Now, the company is chopping 500 jobs nationwide as part of a continued shift to focus more on innovative drugs. The company is cutting jobs in “select sales and headquarters commercial teams” effective Jan. 3.
Merck’s Ebola vaccine wins key European vote
by Jonathan Gardner on October 18, 2019 at 1:59 pm
Erevebo has already been administered to 274,000 people, and data indicate it is effective against the virus currently causing an African outbreak.
AbbVie’s blockbuster hopeful Rinvoq, J&J’s Spravato eye EU rollouts, thanks to new backing
by Kyle Blankenship on October 18, 2019 at 1:57 pm
Painted as the follow-up drug to megablockbuster Humira, AbbVie’s JAK med Rinvoq is already notching blockbuster forecasts, and Johnson & Johnson’s nurturing its own hopes for Spravato. Their preliminary green lights to treat European patients—one of a half-dozen regulators issued Thursday—should give the meds a leg up.
Enzyvant Adds Compass’s Jeb Ledell as Its Chief Operating Officer
by Sarah de Crescenzo on October 18, 2019 at 12:22 pm
Enzyvant, a Cambridge, MA-based rare disease drug developer, has appointed Jeb Ledell as its chief operating officer. Ledell previously held COO roles at Cambridge-based Compass Therapeutics and at Horizon Discovery Group, a genomics company in the UK. Enzyvant’s lead candidate, RVT-802, a regenerative treatment for pediatric congenital athymia, is expected to receive an FDA decision in
The best in the UK healthcare system celebrated at QiC Diabetes awards 2019
on October 18, 2019 at 11:59 am
Award programme recognises work of NHS teams and individuals
Pyxis Oncology Taps MedImmune’s Herbst as Chief Scientific Officer
by Sarah de Crescenzo on October 18, 2019 at 11:54 am
Pyxis Oncology, an immuno-oncology company developing antibody drugs to restore activity to dysfunctional T cells, has appointed Ronald Herbst as its chief scientific officer. Herbst joins the Boston-based company from the AstraZeneca (NYSE: AZN) global biologics R&D arm, MedImmune, where he was vice president of research and development and head of oncology research.
Merck wins CHMP recommendation for Ebola vaccine
on October 18, 2019 at 11:52 am
Has also been granted priority review by FDA
Bio Roundup: Ichnos Emerges, Beyond CAR-T, BridgeBio Bails & More
by Frank Vinluan on October 18, 2019 at 11:49 am
New brand-name drugs typically grab the life science headlines. A venture capital firm will invest tens of millions to develop one and a pharmaceutical company hopes to recoup hundreds of millions by selling it. But a shortage of one particular chemotherapy is showing the crucial role generic drugs play in healthcare. This week, The New
Roche scores another FDA approval for Xofluza
on October 18, 2019 at 11:07 am
Expands use to patients at high risk of flu-related complications
56% rise in GPs seeking mental health help in last year
on October 18, 2019 at 11:01 am
As a results, NHS Practitioner Health plans to recruit around 40 additional clinicians and grow its therapist network.
BMS, Pfizer turn to Fitbit for atrial fibrillation detection
on October 18, 2019 at 10:58 am
AFib is the most common type of irregular heartbeat and is a significant risk factor for stroke.
Xofluza bags FDA approval for flu complications
on October 18, 2019 at 10:52 am
The drug is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from the flu.
CHMP U-turn for Evenity
on October 18, 2019 at 10:48 am
The approval is for severe osteoporosis in postmenopausal women at high risk of fracture.
NICE ‘ok’ for Bayer’s Xarelto
on October 18, 2019 at 10:43 am
The drug is an anticoagulant that targets Factor Xa, approved to prevent atherothrombotic events in coronary artery disease.
Medical cannabis: Growth by leaps and bounds
on October 18, 2019 at 10:06 am
This article follows parts one and two of our trio of in-depth pieces focusing on the growing medical cannabis phenomenon. In June 2019, Pharmafocus visited the headquarters of cannabis company Canopy Growth in the Canadian town of Smiths Falls. Louis Goss investigates how the industry is taking off in Canada and how this might inform the evolution of medicinal cannabis legislation in the UK. read more
CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal
on October 18, 2019 at 10:03 am
Initially received a negative opinion of the drug
Top Ten most popular articles on Pharmafile.com this week
on October 18, 2019 at 10:00 am
It’s time for a rundown of the top 10 articles on PharmaFile this past week. The past seven days saw the first and only transdermal patch for schizophrenia being approved and additionally a new UK medicines bill which could see faster access to key conditions such as dementia and Alzheimer’s. Furthermore there were three FDA approvals for a variety of different conditions. 10. Lilly’s pegilodecakin combo falls at Phase 3 in pancreatic cancer read more