Recon: FDA Approves Alnylam’s Givlaari to Treat Acute Hepatic Porphyria; Vertex Lands French Reimbursement for Orkambi

• Generic-Drug Approvals Soar, But Patients Still Go Without (WSJ)
• A $5 Billion Cholesterol Bet May Be an Overreach (Bloomberg)
• FDA Approves Alnylam’s Givlaari to Treat Acute Hepatic Porphyria (Focus)
• Bankrupt biopharmas are rare. 2019 has some worried that’s changing. (BioPharmaDive) (Axios)
• 31 biopharmas at high risk of bankruptcy in 2020 (BioPharmaDive)
• AbbVie lines up a new preclinical R&D alliance with the dealmakers at natural killer player Dragonfly (Endpoints)
• Bristol-Myers misses main goal of late-stage skin cancer trial (Reuters) (Endpoints) (Press)
• Lilly putting $400M into US diabetes production, adding 100 jobs (Fierce) (Endpoints)
• Top GOP senator: Drug pricing action unlikely before end of year (The Hill)
• Pharmacy chains face October 2020 trial over their role in the opioid crisis (Washington Post)
• States AGs Agree to Longer Halt on Purdue Family Claims (WSJ)
• OxyContin maker Purdue Pharma to pay states' lawyers, urged to help victims (Reuters)
• AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility (MedtechDive)

• Fake doctors, pilfered medical records drive Oxy China sales (AP)
• China plans to add more drugs to price-slashing bulk-buy program (Reuters)
• London biopharma-focused GHO Capital claims close of largest-ever Euro fund (Endpoints) (Press)
• Vertex's stellar quarter carries on with French reimbursement deal (Endpoints)
• Sanofi to assimilate Aetion's real-world data platform into its own (Fierce) (Press)
• Scotland leading the UK in life science start-up growth, report reveals (Pharmafile)
• J&J’s new Darzalex formulation OK’d for use in Europe (PMLive)
• How Sustainable Is England’s Cancer Drugs Fund? (Pink Sheet-$)
• New Deal To Boost Progress On African Medicines Agency (Pink Sheet-$)
• Asian private equity group to buy Lumenis in $1B deal (MedtechDive)
• WHO Drafts Guideline on Data Integrity for Pharmaceuticals (Focus)

• New, old drugs may offer fresh ways to fight heart disease (AP)
• Mystery solved: The American Hospital Association and CVS Health formed a shadowy, anti-pharma group with deep GOP ties (STAT)
• Here’s Why Pharmaceutical Companies Raise Their Prices So Much (Forbes)
• Novartis, Merck KGaA and Biogen: Which new MS drug do doctors like best? (Fierce)
• Reata Rakes In $505M to Advance Development of Two Rare Disease Drugs (Xconomy)
• FDA Warns Three Drugmakers, Diagnostic Company (Focus)
• Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program (Pink Sheet-$)
• Breast cancer drug approvals by the US FDA from 1949 to 2018 (Nature)
• New California Law May Expand Use Of HIV Prevention Drugs, With Caveats (KHN)
• US FDA's Stein: 'Cognitive Dissonance' Exists Between Review Divisions In Regulation Of Biosimilars (Pink Sheet-$)
• Single Database Of FDA Actions Could Improve Drug Development, Sanofi Says (Pink Sheet-$)
• New Tech Payment For Old Antibiotic: US Medicare Effort Brings Lots Of Interest (Pink Sheet-$)
• Alzheimer's Trial: Lessons From a Failed Drug (Medpage)
• MPM and Longwood-backed Werewolf Therapeutics grabs $56 million to take tumors by night (Endpoints)
• FDA is urged to probe a Louisiana program for ‘illegally’ testing an addiction treatment on inmates (STAT)
• Tissium raises €39M to advance tech with drug delivery uses (Fierce)
• Bischofberger-helmed Kronos nabs Celgene research exec as new CMO (Fierce)
• Teeth, They Must Be Very Much Worthwhile: GAO Report on REMS Abuses Notes Lack of Agency Enforcement (FDA Law Blog)
• Omega-3 oils boost attention as much as ADHD drugs in some children (Reuters)
• Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry (FDA)
• List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations (FDA)
• Kymera hands the helm to Novartis vet — and founding CSO — Nello Mainolfi (Endpoints)
• Some bipartisan support for biosimilars is good. More would be better (STAT)
• Letting academic medical centers make CAR-T drugs would save billions (STAT)
• Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (FDA)
• Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity. (FDA)

• Allergan's acute migraine therapy ubrogepant shows strength at Phase 3 (Pharmafile)
• Hope Biosciences Receives FDA Approval to Commence Groundbreaking Stem Cell Clinical Trial for Alzheimer’s Disease (Press)
• Merck KGaA, Darmstadt, Germany, Announces Orphan Drug Designation for Investigational Therapy Tepotinib in Patients with NSCLC Harboring MET Gene Alterations (Press)
• CStone announces first patient dosed in the Phase I bridging registrational study of ivosidenib (Press)

• Incoming Medtronic CEO to prioritize 'aggressive' tuck-in M&A, 'reinvigorating' diabetes unit (MedtechDive)
• Two More Deaths Linked to Intra-aortic Balloon Pumps (Focus)
• Edwards has edge over Medtronic in TAVR registry studies (MedtechDive)
• With eyes on a polymer empire prize, French medtech player seals $42M in fresh funding (Endpoints)
• Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear (GenomeWeb)
• Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA (GenomeWeb)
• BioVentrix wins breakthrough nod for transcatheter-based structural heart device (MassDevice)
• New Carestream Digital Imaging Offerings Receive FDA Clearance (Press)
• Health tech startups should start working with FDA sooner rather than later (mobihealthnews)

• How consultants shopped Verma (Politico)
• Warren and Sanders: More scrutiny needed of commercial boards that decide whether to green-light clinical trials (STAT)
• American Medical Association calls for total ban of non-FDA approved vaping products (CNBC)
• America's 'Shame': Medicaid Funding Slashed In US Territories (NPR)
• PTAB to Hold Inter Partes Review of GSK Vaccine Patent (FDANews-$)
• Fed. Circ. Upholds Mylan's PTAB Win On Insulin Drug Lantus (Law360-$)
• Opioid MDL Judge Plots New Bellwether Trials Across US (Law360-$)

• FDA Advisory Committee Calendar
• 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program – 5 December 2019

• EC Offers Help to Wholesalers on GDP Inspections (Focus)
• France pledges more cash and debt relief for hospitals to quell unrest (Reuters)
• Dutch hospitals close down as workers strike for higher pay (Reuters)

• Asia Regulatory Roundup: TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites (Focus)
• Astellas Beats Rivals To Japan HIF-PHI Market As Roxadustat Launched (Scrip-$)
• Presentations at 24th AHWP Annual Meeting, Muscat, Oman, 11-14 November 2019 (AHWP)

• Ministry, Niti Aayog at odds over regulation of medical devices (Economic Times)
• India’s top-10 selling drugs dominated by diabetes products (PharmaLetter-$)
• Gujarat FDCA in association with DIA, US FDA, EMA & EDQM rolls out series of workshops on API regulations (Pharmabiz)

• TGA presentations: 2019 BAA Conference, 31 October - 1 November 2019 (TGA)

• Tandem Diabetes Care Announces Health Canada Approval of t:slim X2 Insulin Pump with Basal-IQ Predictive Low-Glucose Suspend Technology (Press)

• Brazil update: ANVISA readies change application system, lists top medical device regulatory priorities (Emergo)

• What are the symptoms of anal cancer? Disease is on the rise in the US (NBC)