Regulatory Focus™ > News Articles > 2019 > 12 > Recon: FDA Authorizes First Newborn DMD Screening Test; Amgen, UCB Osteoporosis Drug Evenity Wins EU

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

Posted 12 December 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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 $230M raise and high local interest (Endpoints)
  • AstraZeneca joins Merck, Bristol-Myers in China's checkpoint race as regulators OK first PD-L1 (Endpoints) (Fierce) (Press)
Pharmaceuticals & Biotechnology
  • The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program (Pink Sheet-$)
  • 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-$)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
 Medical Devices
  • 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: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
India
  • 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)
Australia
  • TGA investigation - potential contamination with N-nitrosodimethylamine (TGA)
  • Evidence requirements for listed medicines (TGA)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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