BioPharma Today

Latest News From "The Pink Sheet" DAILY - Mylan And Biocon Partner To Develop Insulin Biosimilars

FDA Panel Rejects Guerbet's Imaging Drug Dotarem For Young Children The gadolinium-based contrast agent should be approved for use in adults and older pediatric patients, but more data are needed to support a novel indication for children under two years old, the Medical Imaging Drugs Advisory Committee says.

Coming In Wednesday's "The Pink Sheet" DAILY - FDA Raises Questions About Data For Imaging Agent Dotarem

FDA approved Macleods Pharmaceuticals’ ANDA for generic Actos, apparently after Ranbaxy waived its rights to 180-day exclusivity. However, Mylan and Watson also share the 180-day exclusivity.

FDA questions sufficiency of pediatric efficacy and safety data for Guerbet’s imaging agent Dotarem ahead of advisory committee review.

It’s the third exit of the year for Avalon Ventures, a hybrid venture capital group that stakes both life sciences and technology start-ups. On Feb. 12, Avalon portfolio company RQx Pharmaceuticals, focused on novel small-molecule antibiotics for drug-resistant Gram-negative bacteria, has reached a $111 million discovery collaboration with Genentech.

 

Latest News From "The Pink Sheet" DAILY - Protein Sciences' Virus-Free Flu Vaccine Clears FDA

Should Opioids Be Used Solely For Severe Pain? FDA Seeks Expert Advice The agency is holding a public meeting in February to obtain information on opioid treatment for chronic pain; FDA seeks data to assess whether to restrict use and establish a maximum daily dose.

Protein Sciences To Begin Selling Novel Flu Vaccine; Flublok Has Virus-Free Appeal The trivalent vaccine can be produced much faster than traditional vaccines and could be modified to compete with quadrivalent formulations. 

QRxPharma's Dual-Opioid Therapy MoxDuo Will Face FDA Cmte. Scrutiny FDA told the company there is no precedent for reviewing a combination product that contains two drugs from the same class. The company's NDA resubmission for the morphine/oxycodone immediate-release product will include oxygen saturation data from a study originally conducted for European regulators.

Reps. Brady, McDermott Trade For Ways And Means Health Panel Posts The top posts of the House Ways and Means Committee's Health Subcommittee will be taken over by newcomers to the panel, with Kevin Brady, R-Texas, as chairman and Jim McDermott, D-Wash., as ranking member.

Pressure Builds On U.K. Government To Conclude Value-Based Pricing Deal With Industry An influential parliamentary committee has called on the U.K. to reveal its plans for value-based pricing by the end of March so that companies, clinicians and patients can adjust to the change, which is expected to start in 2014.

“The Pink Sheet” DAILY - daily in-depth analysis of the key developments shaping the biopharma industry. For more information call 1-800-332-2181. To register for a free trial, click here  – no credit card needed.

 

Coming In Tuesday's "The Pink Sheet" DAILY - AstraZeneca Inks Deal With Vanderbilt Center

The Supreme Court decided not to review the scope of the Hatch-Waxman Act’s infringement safe harbor in GlaxoSmithKline v. Classen Immunotherapies Inc. The court also denied a certiorari petition by Apotex seeking review of a ruling that upheld the validity of Otsuka’s Abilify patent, and a petition by Mylan challenging a decision that Cephalon's cyclobenzaprine extended release patents are valid. 

Latest News From "The Pink Sheet" DAILY - FDA Panel Clears J&J Diabetes Drug With Limitations

Canagliflozin Should Have Limitations Based On Renal Function, Panel Says Several advisory committee members on both sides of a 10-5 vote voiced concern about using Janssen's diabetes drug in patients with moderate renal impairment.

Insomnia Drug Development Programs Must Include Driving Studies, FDA Says Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept's Intermezzo. 

Ultragenyx Takes On Rare Childhood Disease With In-licensing Deal Rare disease company Ultragenyx has in-licensed the North American rights to a treatment for fatty-acid oxidation disorder, adding its third clinical-stage drug to its ultra-rare disease pipeline. 

GSK Will Be A Limited Partner In Sanderling Ventures' New Fund The pharma pledges $50 million to the California firm's new seventh round, which it anticipates closing more than eight years after its sixth. For GSK, it's the latest tie-up with a VC firm as part of a regional investment strategy.

“The Pink Sheet” DAILY - daily in-depth analysis of the key developments shaping the biopharma industry. For more information call 1-800-332-2181. To register for a free trial, click here  – no credit card needed.

Coming In Wednesday's "The Pink Sheet" DAILY - Janssen's Diabetes Drug To Get FDA Panel Review

Janssen Pharmaceutical’s diabetes drug canagliflozin goes before a Jan. 10 FDA advisory committee meeting without the malignancy concerns that derailed dapagliflozin, the first SGLT2 inhibitor to go through FDA review. However, there are questions about cardiovascular safety that did not arise with the AstraZeneca/Bristol-Myers Squibb drug.

Latest News From "The Pink Sheet" DAILY - Merck Is Optimistic About Its Pipeline

U.K.'s NICE Clears Lucentis For Treating Diabetic Macular Edema The U.K.'s cost-effectiveness agency gave a clear OK to Lucentis as an option for treating visual impairment caused by diabetic macular edema after Novartis provided a bigger price discount and updated analyses showing the drug's superior relative effect among a sub-group of people with the condition. 

AbbVie CEO Emphasizes Humira Growth Plans, Potential Of HCV Program AbbVie should appeal to long-term investors due to its sustainable business base and plan to issue and increase dividends over time, says CEO Richard Gonzalez.

First Non-Hormonal Hot Flash Drugs Could Clear FDA Panel In March Depomed's gabapentin and Noven Pharmaceuticals' paroxetine to get advisory committee review for a menopausal hot flash indication; while Phase III data for both drugs are positive, certain endpoints did not reach statistical significance in at least one study.

Merck's Frazier Optimistic About Pipeline Future Merck's Ken Frazier spoke about his faith in anaceptrapib, despite the recent failure of Tredaptive, at the recent Goldman Sachs Conference. He also addressed Merck's pipeline and consolidation in the industry.

GSK's COPD Drug Gets A New Name (Breo) But May Face Familiar Challenges At FDA Panel The respiratory drug's fate is uncertain given its mixed Phase III trial results; in two pivotal studies Breo, formerly Relovair, failed to demonstrate superiority to GSK's Advair.

Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market FDA advisory committee scheduled for Valentine's Day is key test for Guerbet's efforts to get its MRI imaging agent a wider indication than Bayer's Gadavist.

“The Pink Sheet” DAILY - daily in-depth analysis of the key developments shaping the biopharma industry. For more information call 1-800-332-2181. To register for a free trial, click here – no credit card needed.

Coming In Wednesday's "The Pink Sheet" DAILY - Teva Acquires Rights To Xenon's Pain Drug

Questions about how specific FDA should be in recommending contraception for women taking a drug with the potential to cause birth defects are on the agenda for the Dec. 13 session of the Drug Safety and Risk Management Advisory Committee. 

Latest News From "The Pink Sheet" DAILY - FDA Okays Expanded Use Of Zytiga Prostate Cancer Drug

PDUFA V Late-Cycle Review Meetings Need Limited Focus, FDA Says Agency staff are concerned that mandatory meetings with NME/novel biologic sponsors late in the review cycle will result in a forum for extensive debate and a flood of new submissions and appeals, Office of New Drugs Director Jenkins said at Elsevier Business Intelligence's FDA/CMS Summit.

Latest News From "The Pink Sheet" DAILY - FDA Touts Innovative Drug Approvals In FY 2012

Moderna To Focus On Messenger RNA Approaches To Recreate Therapeutic Proteins The latest biotech to emerge from Flagship Ventures' incubator is Moderna, which plans to focus on rare diseases in-house while out-licensing its technology for larger indications.