The Latest
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Sobi's late-breaking ASH data also spurs an approval
Emapalumab, to be branded as Gamifant, is now OK'd in the U.S. for patients with a rare inflammatory disease known as primary HLH.
Clinical Trials -
Sage faces delayed decision on postpartum depression drug
The FDA needs more time to review a REMS plan Sage proposed for Zulresso, resulting in a three-month extension to the drug's PDUFA date.
Regulatory / Compliance -
Bavencio falls short in ovarian cancer study
The setback is the third miss for Pfizer and Merck KGaA's checkpoint inhibitor, which is being tested in three other late-stage studies of the tumor type.
Clinical Trials -
Leo, PellePharm strike rare disease deal
The agreement directs Leo Pharma into the world of rare disease therapeutics, a route increasingly taken by drugmakers.
Mergers and Acquisitions / Deals -
Aimmune's peanut allergy drug draws mixed reactions
Publication in NEJM of the PALISADE data reinforced analysts' confidence in AR101, but also may have stoked some safety concerns among investors.
Clinical Trials -
Kaleo under fire for price hikes on naloxone treatment
Kaleo raised its price for Evzio from $575 to $4,100 in fewer than three years. Now, the company's tactics are the focus of a new Senate report and a "60 Minutes" segment.
Marketing -
Roche pulls EU application for Tecentriq in kidney cancer
The immunotherapy delivered positive results back in February, but Roche no longer believes that data to be supportive of a label extension.
Regulatory / Compliance -
FDA plan would ease regulations for prescription drug apps
The regulator proposes to treat software like dose calculators or symptom trackers as promotional labeling, aiming to boost development of digital tools.
Regulatory / Compliance -
FDA clears new Adcetris use in speedy review
Through an experimental real-time process, the regulator approved Seattle Genetics' application for the drug in just two weeks.
Regulatory / Compliance -
Pfizer tests Trump with plans to hike prices on 41 drugs
Last month, Pfizer CEO Ian Read indicated the pharma would soon return to "business as normal" after a rare reversal on price hikes made in July.
Marketing -
7 drugs that raised eyebrows in Q3
Biosimilars began to bite into blockbuster franchises, while newer products propped up sales at Sanofi, Regeneron and GSK.
Marketing -
MYSTIC deals another blow to AstraZeneca as Imfinzi misses on OS
Analysts said "statistical issues" could be behind Imfinzi monotherapy not delivering on overall survival in the first-line non-small cell lung cancer setting.
Clinical Trials -
3 hemophilia patients lift uniQure's value more than $450M
After six weeks, hemophilia B patients who received the biotech's gene therapy had Factor IX levels thought to significantly reduce the risk of bleeding events.
Clinical Trials -
Blueprint posts 'impressive' data for lead candidate, but investor response tepid
One Wall Street analyst said Blueprint's lead drug candidate is shaping up to have a best-in-class profile after reviewing fresh clinical trial results.
Clinical Trials -
Boehringer, Epizyme take aim at 'undruggable' cancer targets
A new deal between the companies focuses on two epigenetic targets linked with the development of cancer.
Mergers and Acquisitions / Deals -
United Therapeutics licenses Arena's hypertension drug for $800M
The deal may help United, a company almost entirely focused on pulmonary arterial hypertension medicines, compete with main rival Johnson & Johnson.
Mergers and Acquisitions / Deals -
California, Massachusetts go toe-to-toe for title of best biotech hub
For yet another year, the two states put out reports showcasing statistics that back why they ought to be called biopharma's No. 1 hub.
Marketing -
ICER finalizes report finding asthma biologics too pricey
After taking comments from the drugmakers into consideration, ICER's main takeaway was unchanged: these drugs are overly expensive.
Corporate News -
Express Scripts plans 'Flex' formulary focused on authorized generics
Gilead’s generic versions of its own hepatitis C treatments Epclusa and Harvoni are first on the list for the new formulary, which starts Jan. 1.
Marketing -
Specialty drugs drive Rx spending increase, Blue Cross says
Insurers under the Blues' umbrella, which accounts for dozens of independently run payers, spent about $100 billion on prescription drugs in 2017.
Marketing -
Sobi snags rights to AstraZeneca drugs in another immunology play
"Immunology now becomes the second leg to Sobi and it helps us to articulate what specialty care is about," the company's CEO said on the deal.
Mergers and Acquisitions / Deals -
AbbVie showcases Mavyret's curative power with shorter regimen
The aim of EXPEDITION-8, a Phase 3b study, was to see if 8-week dosing would work in treatment-naive hep C patients with compensated cirrhosis.
Clinical Trials -
Solid's manufacturing work allows trial to restart
After a challenging year, it looks as though Solid Biosciences' gene therapy for Duchenne muscular dystrophy is back on track.
Clinical Trials -
Amarin's Vascepa trial stirs data debate as stock drops 10%
A five-year clinical trial showed strong heart benefits for the fish oil-based pill, but questions on the placebo used in the study have raised doubts as well.
Clinical Trials -
'Super'-responder analysis gives more power to Viking's fatty liver drug
VK2809 reduced liver fat content by 50% or more in 67% of patients, the analysis found, further supporting Viking's view that its drug could help with both NAFLD and NASH.
Clinical Trials