Recon: FDA Expands Roche’s Xofluza for High Risk Patients; Merck to Cut 500 US Sales Jobs

• Merck is taking the ax to its US operations, cutting 500 jobs in its latest reorganization (Endpoints) (Inquirer)
• FDA expands Xofluza approval as Roche struggles to catch looming flu market (Endpoints) (Press)
• Pelosi Drug Pricing Bill Advances on Party-Line Votes (Focus) (Politico) (CNBC)
• Verma: Drug 'innovation doesn't mean anything' if it's too costly (Modern Healthcare)
• Judge's unorthodox approach has huge opioid settlement within reach (Reuters)
• US vaping-related deaths rise to 33, cases of illness to 1,479 (Reuters)
• Unlicensed medical 'cures' are flourishing in closed Facebook groups, where cancer treatments — and even surgery — are sold beyond the reach of the law (Business Insider)
• We Found Over 700 Doctors Who Were Paid More Than a Million Dollars by Drug and Medical Device Companies (ProPublica)

• Time is of the essence for patients who have serious and life-threatening conditions. Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

• Sanofi pulls Zantac from US and Canada after carcinogen found (Reuters) (Press)
• Canadian breakthrough that became the world's most expensive drug, then vanished, gets second chance (CBC)
• Merck KGaA wants to get in early on Chinese innovation — so it's setting up a seed fund there (Endpoints)
• NICE ‘ok’ for Bayer’s Xarelto (PharmaTimes)
• UK Signs Three More No-Deal Brexit Drug Transport Contracts (Pink Sheet-$)
• Drug Pricing Transparency To Be Discussed At World Trade Organization (Health Policy Watch)
• EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR (Focus)

• People are going online for abortion pills, especially in states with more restrictions (NBC)
• DNA Tests For Psychiatric Drugs Are Controversial But Some Insurers Are Covering Them (NPR)
• Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance (Focus)
• ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often? (Pink Sheet-$)
• The FDA’S take on Medical Innovation (PharmaLetter-$)
• Clinigen launches programme to provide Azedra outside US (PharmaTimes)
• Chiesi announces two successful sets of asthma data (PharmaTimes)
• Pfizer’s Vyndaqel franchise, buoyed by diagnoses, is poised for ‘a decisive beat’: analyst (Fierce)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Top ALK expert and cancer drug researcher Alice Shaw bids adieu to academia, hello to Novartis (Endpoints)
• Ronald Herbst follows MedImmune exodus to Pyxis CSO post; Jeff Goddard to succeed CEO of AIT Bioscience (Endpoints)
• Ansun Biopharma closes $80M Series B; RedHill Biopharma ties up with Cosmo Pharmaceuticals (Endpoints)

• Dermira Presents Data From Phase 2b Study of Lebrikizumab in Patients With Atopic Dermatitis at Fall Clinical Dermatology Conference (Press)
• Isofol Receives Positive Feedback From PMDA in Japan, Expanding Ongoing Global Pivotal Phase 3 AGENT Trial in First Line Metastatic Colorectal Cancer (Press)

• OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020 (Focus)
• Concept Medical wins CE Mark for MagicTouch DCBs (MassDevice)
• Georgia to investigate BD medtech sterilization plant (MassDevice)

• J&J to recall some baby powder as FDA finds traces of asbestos (Reuters)
• Juul halts all U.S. sales of many flavored nicotine liquids (Reuters)
• Rx Patent Reform Gets Renewed Interest From GOP As Alternative To Price Negotiation (Pink Sheet-$)
• How Pending Decision on Obamacare Could Upend 2020 Campaign (NYTimes)
• Competitor accuses 23andMe of ‘false negatives’ in cancer-gene testing (STAT)
• As Osiris moves on from fraudulent past, one exec settles up with SEC (Endpoints)
• Whistleblower Alleges Fraud At A Large Medicare Advantage Plan In Seattle (NPR)
• 95 percent of baby foods tested contain toxic metals, new report says (NBC)
• Actavis Asks Full Fed. Circ. To Nix 'Amorphous' Panel Ruling (Law360-$)
• Insys Exec Trial Fair Despite Alleged Weil Conflict, Judge Says (Law360-$)
• Boston Scientific Sanctioned For 'Shenanigans' In FCA Suit (Law360-$)
• Mylan Case Shows SEC Stance On Disclosing Investigations (Law360-$)
• AmerisourceBergen Brass Sued In Del. Over Drug Scheme (Law360-$)
• USPTO Publishes Update to Its Subject Matter Eligibility Guidance (Patent Docs)
• Expert’s “Rebuttal” Report Was Nothing of the Sort in Hernia Mesh Case (Drug & Device Law)
• Southern California Doctor Found Guilty in $12 Million Medicare Fraud and Device Adulteration Scheme (DOJ)

• FDA Advisory Committee Calendar

• Belgium Inspects Companies Delaying or Preventing Biosimilar Competition (Focus)
• New Italian Pricing Decree To Drive R&D Transparency (Pink Sheet-$)
• Clinical trials for medicines: manage your authorisation, report safety issues (MHRA)
• Adrenaline auto-injectors: recent action taken to support safety (MHRA)
• Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions (MHRA)
• Ingenol mebutate gel (Picato▼): increased incidence of skin tumours seen in some clinical studies (MHRA)
• Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation (MHRA)
• Letters and drug alerts sent to healthcare professionals in September 2019 (MHRA)
• Medical Device Alerts issued in September 2019 (MHRA)
• Drug Safety Update: monthly PDF newsletter (MHRA)

• CALL FOR COMMENTS on the PROPOSED document "Competency Framework for Medical Technology Regulators" (AHWP)
• Annual Report 2019 is now available (Astellas)
• Astellas Transfers Three Products in Asia Region to Daiichi Sankyo (Press)

• CDSCO seeks suggestions from stakeholders to improve Sugam portal for effective online processing of applications (Pharmabiz)

• Ebola survivors battle grief and stigma in eastern Congo (Reuters)
• A Nazi Version of DDT Was Forgotten. Could It Help Fight Malaria? (NYTimes)