Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.
Not-for-profit ranks Gilead Sciences and Sanofi as the lowest-scoring drugmakers in terms of clinical trial transparency; Perrigo shareholders to vote on Mylan deal; new Valeant allegations
Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.
One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."
Valeant receives subpoenas over drug pricing; BMS signs new immuno-oncology deal with Five Prime Therapeutics; Pfizer CEO says insurance coverage to blame in price debate
Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner
Sanofi's Aubagio reduces brain volume loss; cancer specialists avoid pricey cancer meds; analysis says placebo effect is on the rise
Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death
Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue
Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy
PhRMA hires Ubl as CEO; two drugs report superior results in kidney-cancer trials compared to the standard of care; Novo Nordisk's shares rise on Tresiba approval
Turing CEO backs down on price hike; Amgen's and Allergan's cancer biosimilar shows positive results; study finds text message reminders can change health behavior
The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.
New analysis says Paxil is not safe or effective for teens; some FDA reviewers voted against Addyi approval over side effects; HHS partners with AstraZeneca on antibiotic development
Obama nominates Robert Califf as FDA commissioner; The Huffington Post debuts investigative series on J&J; Amgen acquires cholesterol-lowering drug
Amarin begins legally promoting off-label uses of its prescription fish-oil drug, while Pacira sues the FDA over the label for its pain drug, Exparel.
Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life
The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.
Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
US patent office declines to review two Ampyra patents; the FDA expands indication for Promacta; the Biosimilars Council argues against CMS proposal for biosimilar coding
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
A new poll conducted by the Kaiser Family Foundation found that most Americans believe drugmakers should be required to release information to the public about how they set drug prices.
Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?
State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
Court blocks generic competition for Opana ER until 2023; lawmakers question Valeant drug price hikes; Roche's immuno-oncology drug meets primary endpoint in mid-stage trial
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