Recon: FDA Authorizes First Newborn DMD Screening Test; Amgen, UCB Osteoporosis Drug Evenity Wins EU Approval

• Big Pharma Will Target Smaller Deals in 2020, JPMorgan Predicts (Bloomberg)
• New drugs show rare promise against advanced breast cancer (AP)
• CVS to increase genetic testing for some Aetna cancer patients (Reuters)
• Gilead's Kite files for FDA approval of second CAR-T therapy (Fierce) (Endpoints) (Press)
• Express Scripts throws a lifeline to digital health start-ups (CNBC)
• Something Ventured: Akrevia Therapeutics and three other startups got venture funding a year ago. Did it help them do what they said it would? (STAT)

• Miracle Cancer Drugs Are Making Big Pharma Billions. Others Are Getting Left Behind (Bloomberg)
• Magic mushroom medicine passes first clinical safety trial (Financial Times) (Endpoints)
• Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning (Xconomy) (PMLive) (Press)
• Shionogi's Mulpleo recommended for NHS use across England, Wales and Scotland for chronic liver disease (Pharmafile)
• EU Ministers Want Decisive Action On Medicines Access & Shortages (Pink Sheet-$)
• The Rise Of Patent Wars In Europe's Gene Therapy Space (Law360-$)
• Intec battered as Novartis ducks out of Accordion collaboration (PMLive)
• Alberta to force patients to switch from biologics to cheaper biosimilars (The Globe and Mail)
• Alphamab Oncology rounds out HKEX's second biotech IPO year with $230M raise and high local interest (Endpoints)
• AstraZeneca joins Merck, Bristol-Myers in China's checkpoint race as regulators OK first PD-L1 (Endpoints) (Fierce) (Press)

• The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program (Pink Sheet-$)
• Aspen Neuro Bags $6.5M to Test Parkinson’s Disease Stem Cell Therapy (Xconomy)
• Pyxis Oncology nabs Pfizer spin-off founder as new CEO (Fierce)
• End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain (Blood Advances)
• Value-based pricing for gene therapy? Maybe not ready for hemophilia (BioPharmaDive)
• Novo Nordisk Targets Smart Insulin, Stem Cell-Therapies (Scrip-$)
• Machine learning for clinical decision-making: pay attention to what you don’t see (STAT)
• Parkinson's transplants emerge as stem cell pioneer Jeanne Loring joins R&D race (Endpoints)
• For sale: Long-acting PhIII GLP-1 diabetes drug that’s way behind rivals, now spurned by Sanofi (Endpoints)
• PharmaLex announces joint venture with Vintura (PMLive)
• Do Pharmaceutical Patents Generate Unique Global Health Duties? (Harvard Bill of Health)
• Finland's Forendo Attracts Big Pharma For Liver Disease R&D (Scrip-$)
• Calls to End Industry’s ‘Financial Entanglement’ With Healthcare Players (Pink Sheet-$)
• Repurposing Pfizer's heart rhythm drug Tikosyn to treat PAH (Fierce)
• Novartis And The Medicines Company: Five Things To Worry About (Pink Sheet-$)

• Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink (Xconomy)
• Lilly launches first of its kind trial for RET fusion-positive NSCLC (PharmaTimes)
• KRAS analysis vaults Merck's flagship Keytruda back into the spotlight (Endpoints) (Press)
• SABCS: Merck's Keytruda notches win in triple-negative breast cancer as Roche's Tecentriq falls short (Fierce)
• SABCS: Pfizer's Ibrance backs up benefit in HER2-negative breast cancer with real-world data (Fierce)
• Novartis Kisqali shows superior survival rates to AstraZeneca’s Faslodex in advanced breast cancer (Pharmafile)
• Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2019 San Antonio Breast Cancer Symposium (Press)
• Amneal Receives Abbreviated New Drug Application Approval for EluRyng™, the First Generic NuvaRing® (Press)
• Data From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's ENHANZE® Drug Delivery Technology To Be Presented At San Antonio Breast Cancer Symposium (Press)
• Moberg Pharma Comments on the Results of the North American Phase 3 Study With MOB-015 (Press)
• SPL Medical Announces First Prostate Cancer Metastasis Patient Diagnosed with Ferrotran® in Compassionate Use Program in Switzerland (Press)
• Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer (Press)
• Nordic Nanovector Provides Update on LYMRIT 37-05 Phase 1 DLBCL Trial (Press)

• Sunlight doesn't dent industry funding to doctors over half-decade (MedtechDive)
• Haemonetics opens new Boston headquarters (MassDevice)
• ImpediMed lands expanded 510(k) clearance for Sozo (MassDevice)

• US watchdog finds $6.7 billion in questionable Medicare payments to insurers (Reuters)
• The showdown between Trump's top health officials continues (Politico)
• PTAB Institutes Fresenius’ IPR On Amgen Pegfilgrastim Patent (BigMoleculeWatch)
• Coherus and Amgen Stipulate to Dismissal of Adalimumab Infringement Case (BigMoleculeWatch)
• AstraZeneca Escapes Biotech Firm's $33.8M Lifted-Data Suit (Law360-$)
• Fed. Circ. Affirms Actavis Infringed Anti-Nausea Drug Patent (Law360-$)
• Fla. Court Won’t Dismiss Pelvic Mesh Discovery Complaint (Law360-$)
• Calif. Fights Bid To Block Pay-For-Delay Law (Law360-$)
• FTC Defends Impax Pay-For-Delay Ruling At 5th Circ. (Law360-$)
• Peter v. NantKwest, Inc. (2019) (Patent Docs)
• Guest Post – Paint It Black: The Ninth Circuit OKs RICO Liability For Failure To Warn About Drug Safety Risks (Drug & Device Law)

• FDA Advisory Committee Calendar

• More on the PRRC (MedicalDevicesLegal)
• Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes (Pink Sheet-$)
• BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044) (MHRA)

• Only 37 drugs found to be NSQ out of 1,158 samples in CDSCO’s routine sample survey in Nov 2019 (Pharmabiz)
• Pharma companies seek hike in drug rates under price control (Economic Times)
• Biocon extends licensing pact with Equillium for itolizumab (Economic Times)

• TGA investigation - potential contamination with N-nitrosodimethylamine (TGA)
• Evidence requirements for listed medicines (TGA)

• Why Women on the Pill Still ‘Need’ to Have Their Periods (NYTimes)
• More Americans Are Dying at Home Than in Hospitals (NYTimes)
• Only a quarter of US childcare centers require kids to have flu shots (Reuters)