FDA: Page 107
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Deep Dive
ICYMI: 3 charts that show why 2014 was a milestone year for US novel drug approvals
"What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening disease," said FDA Commissioner Maggie Hamburg.
By Sy Mukherjee • Dec. 12, 2014 -
Mylan to foot $20M tax penalty for top execs after inversion merger
The excise tax is meant to discourage domicile-shifting deals like the Mylan-Abbott merger.
By Nicole Gray • Dec. 11, 2014 -
FDA approves new HPV super-vaccine, Merck's Gardasil 9
The FDA says the vaccine could prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.
By Nicole Gray • Dec. 11, 2014 -
Indian company first to the finish line with historic Humira biosimilar
AbbVie is officially on notice, and the world's top-selling drug must now take on a much cheaper generic alternative in one of the world's biggest markets.
By Sy Mukherjee • Dec. 10, 2014 -
HHS extends legal immunity to Ebola vaccine makers
Under the Public Readiness and Emergency Preparedness (PREP) Act, HHS has promised to protect vaccine manufacturers from any legal action related to developing and testing their investigational Ebola drugs.
By Nicole Gray • Dec. 10, 2014 -
Feds refuse to hear Sandoz case related to biosimilar development efforts
As the first company to file for a biosimilar approval based on the 351(k) pathway, Sandoz, a Novartis subsidiary, is attempting to forge a path forward.
By Nicole Gray • Dec. 10, 2014 -
Deep Dive
ICYMI: AARP and GPhA on what to do about generic drug price hikes
The AARP's Leigh Purvis and Ralph Neas of the Generic Pharmaceutical Association agree on the need for more generics competition. But they look at the problem through distinct lenses.
By Nicole Gray • Dec. 10, 2014 -
Feds drop wire fraud charges against former Lilly scientists
Former Lilly employees Guoqing Cao and Shuyu Li were accused of stealing confidential drug-related data and wire fraud. But the reason for dropping the charges remains unclear.
By Nicole Gray • Dec. 9, 2014 -
France, Germany, other EU countries suspend Indian generics approvals
France, Germany, Belgium, and Luxembourg are among the countries suspending approval. The reason? Concerns over the quality of Indian clinical data.
By Nicole Gray • Dec. 9, 2014 -
Some more firsts for Incyte: Jakafi approved for chronic bone marrow disease
Jakafi was already the first drug approved for myelofibrosis. Now, it's the first drug approved for treatment of polycythermia vera, a different type of bone marrow disease.
By Nicole Gray • Dec. 8, 2014 -
UPDATED: Jury sides with AZ in crucial pay-for-delay case over Nexium generics
A jury in Boston has sided with AstraZeneca over several payers' groups who challenged the pharma giant's $1 billion Nexium patent suit settlement with generics maker Ranbaxy.
By Sy Mukherjee • Dec. 5, 2014 -
The FDA's new effort to make it easier to create generics of risky drugs
The REMS program was initially implemented to ensure the safe use of risky products; however, some brand name pharma manufacturers have subverted it in an effort to stymie competition.
By Nicole Gray • Dec. 5, 2014 -
Whistleblower: Sanofi, ex-CEO Viehbacher paid out $34M in kickback scheme
A whistleblower suit alleges wrongdoing involving consultants, pharmacy groups, and hospitals. And there's talk that the former Sanofi CEO was involved in the fraudulent activity.
By Nicole Gray • Dec. 4, 2014 -
FDA OKs Amgen's Blincyto to treat rare form of acute lymphoblastic leukemia
Blincyto (blinatumomab) is an immunotherapy-based oncology treatment for a leukemia which kills roughly 1,400 people per year.
By Nicole Gray • Dec. 4, 2014 -
Beyond ABC: FDA finalizes labeling rules for pregnant, lactating women
Pregnant and lactating women—as well as men of reproductive age—will now have a simpler guide to help them understand medication-associated risks.
By Nicole Gray • Dec. 4, 2014 -
Puma Biotech plummets in after hours trading after delaying breast cancer NDA
Neratinib (PB272), Puma's investigational breast cancer drug for metastatic HER-2 positive breast cancer, has performed exceptionally well in phase III clinical trials.
By Nicole Gray • Dec. 3, 2014 -
Sponsored by
What's Hiding in Your Prescription Pills: Color Value Reveals Chemical Purity in Pharmaceutical Grade Talc
Sponsored by: Have you ever wondered exactly what is put into all those pills and capsules that are sitting in your medicine cabinet? Looking at the packaging you will see a list of ‘active ingredients’… but what is all that other stuff? The majority of medic...
Dec. 2, 2014 -
Why BMS is getting ready to slash up to 1,000 jobs in China
Amid corruption probes and market shifts in China, many pharma companies are retrenching. Sales reps will be feeling the brunt of BMS' layoffs.
By Nicole Gray • Dec. 2, 2014 -
Despite deaths, Italian regulators declare Novartis flu vaccine safe—for now
In the last two months, 19 elderly Italian people who received Novartis' flu vaccine, Fluad, have died.
By Nicole Gray • Dec. 2, 2014 -
Report: China considering large-scale eradication of drug price caps
In a move that signals support for a more market-based approach to pharmaceutical drug prices, China's economic planner, the NDRC, is seriously considering lifting drug-price caps.
By Nicole Gray • Dec. 1, 2014 -
EU green lights BI's Vargatef for advanced lung cancer
With five-year survival rates of less than 20%, non-small cell lung cancer (NSCLC) is a deadly diagnosis. But Vargatef increased median overall survival by 20% in large phase III trials.
By Nicole Gray • Dec. 1, 2014 -
Generic drug price hikes move Congress to consider consumer relief measures
Last year, prices for half of all generic drugs increased. In fact, they doubled for 10% of generics.
By Nicole Gray • Nov. 26, 2014 -
Lilly’s once-weekly diabetes drug approved in EU
Trulicity is now available in the EU for patients who want the convenience of a once-weekly treatment option for type 2 diabetes.
By Nicole Gray • Nov. 26, 2014 -
FDA: No decision on Novartis' troubled panobinostat for 3 months
Novartis was expecting a decision on panobinostat this week, but the FDA has announced that the decision won't come for three months. That's actually good news.
By Nicole Gray • Nov. 26, 2014 -
Deep Dive
A lead investigator reveals how Baxter's Hyqvia got its hard-won approval
When Hyqvia was denied FDA approval in 2012, Baxter's clinical research team took a step back and found a way forward. BioPharma Dive spoke to its lead investigator to learn more.
By Nicole Gray • Nov. 25, 2014
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