FDA: Page 68
-
Merck's Keytruda gets first nod in genetically-defective tumors
The anti-PD-1 drug locked down another indication, this time for solid tumors that have defective genetic code.
By Jacob Bell • May 24, 2017 -
Courtesy of Sanofi
Overcoming delay, Sanofi, Regeneron win US approval for RA drug
The two companies said Kevzara will be priced at a 30% discount to the leading TNF-alpha inhibitors Humira and Enbrel.
By Ned Pagliarulo • May 23, 2017 -
Investors claw for Puma shares despite questions from FDA adcomm
The biotech's stock leapt more than 80% Monday morning after the FDA released documents for an upcoming advisory committee meeting. Yet, it's unclear whether the panel experts will share investors' optimism.
By Jacob Bell • May 22, 2017 -
EMA recommends 11 drugs for approval in May meeting
The list of CHMP-backed new treatments included Sanofi's biosimilar Humalog, LEO Pharma's brodalumab and Gedeon Richter's cariprazine.
By Jacob Bell • May 22, 2017 -
Prescribed Reading: ASCO dominates, Icahn BMS interest just a rumor
The abstracts have arrived! Carl Icahn's first quarter holdings are released and J&J gets a black box warning.
By Lisa LaMotta • May 19, 2017 -
FDA
FDA warns of higher amputation risk for J&J's Invokana
Results from two clinical studies showed the risk of amputation was roughly double for the SGLT-2 inhibitor compared to placebo.
By Ned Pagliarulo • May 17, 2017 -
Concert trial on hold while FDA reviews tox studies
The biotech's baldness drug was put on clinical hold by the regulatory agency in order to assess non-clinical toxicology studies.
By Lisa LaMotta • May 17, 2017 -
Editas delays CRISPR move to human trials
The biotech announced a delay for its planned IND filing, giving competitors an opening to start trials in the closely watched field first.
By Lisa LaMotta • May 16, 2017 -
FDA
Taking office, Gottlieb keeps drug pricing front and center
The new FDA head told agency staff he hopes to speed lower cost generics to market and increase competition, particularly for complex drugs and biologics.
By Ned Pagliarulo • May 16, 2017 -
Minerva's schizophrenia drug heads to late stages
The central nervous system drug developer has completed an end-of-Phase 2 meeting with the FDA, and plans to kick off late-stage testing later this year.
By Jacob Bell • May 16, 2017 -
Deep Dive
Solutions to clinical trial adherence remain elusive
Making sure patients take their medications is crucial to clinical trial success, but exactly how to do that remains a daunting task for investigators.
By Jacob Bell • May 15, 2017 -
Prescribed Reading: Checkpoint inhibitors change cancer
Approvals and failures of checkpoint inhibitors have dramatically changed the cancer landscape, and could even have an impact on how the FDA approaches approvals. Elsewhere, Pfizer's getting into genes and Advair avoids competition.
By Lisa LaMotta • May 12, 2017 -
Second Advair copy rejected, giving GSK short-term respite
Hikma Pharmaceuticals said it had received a complete response letter from the FDA, likely meaning GSK will dodge generic competition to its bestseller this year.
By Ned Pagliarulo • May 11, 2017 -
EMA trumpets achievements ahead of Brexit
The European healthcare regulatory authority is touting its success as it hunts for a new home.
By Suzanne Elvidge • May 11, 2017 -
J&J discloses DOJ investigations into marketing, advisory practices
U.S. officials are looking into the healthcare heavyweight's sales protocols for four drugs: Remicade, Stelara, Olysio and Simponi.
By Jacob Bell • May 10, 2017 -
Senate confirms Scott Gottlieb as FDA chief
Gottlieb will have to strike a balance between the Trump administration's push to deregulate and defending the FDA's "gold standard" for reviewing the safety and efficacy of new drugs.
By Ned Pagliarulo • May 10, 2017 -
Roche's Tecentriq fails trial, raising questions about approval
The late-stage failure in bladder cancer now calls into question the FDA's initial decision to OK the drug.
By Lisa LaMotta • May 10, 2017 -
Bavencio snags bladder cancer approval ahead of goal date
The FDA's accelerated approval of Merck KGaA and Pfizer's checkpoint inhibitor means more competition in second-line bladder cancer.
By Suzanne Elvidge • May 10, 2017 -
Scynexis stock slumps as clinical hold continues
The FDA's request for more analysis of preclinical and clinical data looks like it will push further clinical development of Scynexis' IV antifungal even further back.
By Suzanne Elvidge • May 10, 2017 -
FDA rejection sets back TherapeuticsMD
The FDA's request for 12-month safety data on TherapeuticsMD's hormone product for post-menopausal women could mean a missed chance at market.
By Suzanne Elvidge • May 9, 2017 -
FDA clears new ALS drug for US market
Radicava, only the second drug ever approved specifically for ALS in the U.S., will retail for over four times its price tag in Mitsubishi Tanabe's homeland, Japan.
By Suzanne Elvidge • May 8, 2017 -
Prescribed Reading: Deals to come, but when?
Pfizer and Gilead could be in a deal-making mood, while the FDA continues to approved drugs at a rapid clip and clinical failures keep coming.
By Lisa LaMotta • May 5, 2017 -
House narrowly passes GOP plan to replace ACA
The measure dismantles key ACA provisions such as essential health benefits and pre-existing condition protections.
By Jeff Byers , Shannon Muchmore • May 4, 2017 -
Q1 Biotech earnings highlights: Clovis, Bluebird, Rigel, Vanda
Unlike their big pharma counterparts, small biotechs don't have much revenue to report, but earnings updates can still be valuable.
By Lisa LaMotta • May 4, 2017 -
Insulin makers targeted in pricing inquiries
Eli Lilly disclosed it is under investigation by the attorneys general of Washington and New Mexico. Rival Novo Nordisk is under similar scrutiny.
By Suzanne Elvidge • May 3, 2017
Previous
