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Regulatory Focus™ > News Articles > 2019 > 11 > Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

Posted 26 November 2019 | By Michael Mezher 

Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill (STAT)
  • FDA approves Global Blood Therapeutics sickle cell disease drug (Reuters) (STAT) (FDA)
  • Pharma execs tell researchers that multiple sclerosis drug pricing is based on competition, not R&D costs (STAT)
  • FDA approves J&J spinout's device for kids with recurring ear infections (MedtechDive) (FDA)
  • In pricing our gene therapy, Bluebird weighed value, shared risk, and a lifetime cap (STAT)
  • US heart patients cut back on life-saving drugs due to cost (Reuters)
  • US charges former Outcome Health executives in $1 billion fraud (Reuters) (WSJ) (AP)
In Focus: International
  • New Roche flu drug can drive resistance in influenza viruses: researchers (Reuters) (Endpoints)
  • Cancer Drug Doubled Korean Pharma Stock on Award It Never Won (Bloomberg)
  • Veloxis wins $1.3B buyout deal, and the new owner plans to follow up with new deals (Endpoints) (Japan Times)
  • Merck is probed by Spain’s antitrust regulator for allegedly delaying competition for a contraceptive (STAT)
  • After FDA OK, SK to breath new life into Korean biotech with $850M IPO (Endpoints)
  • Cancer vaccine play MaxiVAX shoots for 'hard endpoint' in PhII head & neck cancer test (Endpoints)
  • Mavenclad granted accelerated access by NICE (PharmaTimes)
  • Europe approves first subcutaneous version of biosimilar infliximab (Pharmafile)
  • Singapore and South Korea agree to cooperate on Good Manufacturing Practice (Pharmafile)
  • Measles Cases Continue to Rise Around the World (NYTimes)
Pharmaceuticals & Biotechnology
  • US lawmakers call for FDA office in Israel (Pharmafile)
  • Pharma execs: Thirst for profit drives high drug prices (The Oregonian)
  • OND Reorganization Continues Apace (Focus)
  • There’s one endpoint that the booming biopharma industry has failed at miserably: financial toxicity (Endpoints)
  • FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables (Focus)
  • OPDP Letter Criticizes Drug Company for Failing to Disclose Risk Info Online (Focus)
  • Presence of Piracetam in Cognitive Enhancement Dietary Supplements (JAMA)
  • Our drug policy often prioritizes eliminating rare disease. One researcher asks: Is that the right goal? (STAT)
  • ICER gets on board with AbbVie's Rinvoq for RA but frets over 'fair pricing' of next-gen drugs (Fierce)
  • FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns (FDA)
  • Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? (The Niche)
  • US FDA's New Neurology Leadership Likely To Face Two Big Reviews In 2020 (Pink Sheet-$)
  • Complex Generics May Need New Communications Options In GDUFA III (Pink Sheet-$)
  • Comparative Claims: CFL Guidance Gives Opening; OPDP Research May Close It (Pink Sheet-$)
  • Karuna's 'A-ha moment': A billion-dollar stock swing and new expectations (BioPharmaDive)
  • La Jolla CEO decamps just as biotech faces a reckoning for iron overload drug (Endpoints)
  • Five Questions With a16z’s Vijay Pande on AI and Making New Drugs (Xconomy)
  • Acadia's sweeping hunt for better Nuplazid data bags mixed results for schizophrenia (Endpoints)
  • Prospective Grant of an Exclusive Patent License: Gene Therapy for Ocular Disease (NIH)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Janssen's INVOKANA (canagliflozin) Gets Boost Over Competitors with FDA Approval for Diabetic Kidney Disease and a Newly Minted Collaboration with Renal Giant, Vifor Pharma (Press)
  • Imbrium Therapeutics L.P. and SpineThera, Inc. Announce First Patient Dosed in Phase 1/2 Clinical Study (Press)
  • Delta-Fly Pharma, Inc. Initiated Phase 3 Clinical Study of DFP-10917 and Phase 1 Clinical Study of DFP-14927 (Press)
  • VFMCRP and ChemoCentryx Announce Positive Topline Data From Pivotal Phase-III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA Associated Vasculitis (Press)
  • Poxel Announces Positive Topline Results for Imeglimin Phase 3 Trial (TIMES 3 36-week) for the Treatment of Type 2 Diabetes in Japan (Press)
  • Cerevel Therapeutics to Present Safety, Tolerability, and Pharmacokinetics Results From Phase 1 Trial of CVL-865 (Press)
  • Prokarium Announces MHRA Acceptance to Run Phase I Trial of Lead Vaccine Against Enteric Fever (Press)
Medical Devices
  • Second MDR Corrigendum Targets Class I Devices (Focus)
  • CDRH Unveils Pilot Project for Sterilization Changes (Focus)
  • Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis (MedtechDive)
  • 5 insights into Dexcom's year ahead from CEO Kevin Sayer (MedtechDive)
  • US Medical Innovations Receives FDA 510(k) Clearance for the Canady Plasma Smart XL-1000 Generator (Press)
  • Tusker Medical’s pediatric ear tubes land breakthrough device designation (MassDevice)
  • Venus Concept wins CE Mark and Health Canada approval (MassDevice)
US: Assorted & Government
  • Continuing Resolution Keeps FDA Funded Through Dec. 20 (FDA News-$)
  • Time to Talk Turkey … Once Again (Alliance for a Stronger FDA)
  • Upton and DeGette Begin Work on Cures Act Reprise (Focus)
  • Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation (Big Molecule Watch)
  • Standards body urged to add device identifiers to insurance claims forms (MedtechDive)
  • The $11 Million Dollar Medicare Tool That Gives Seniors the Wrong Insurance Information (ProPublica)
  • CRISPR Housekeeping (Patent Docs)
  • What a Difference a Year Makes (Or Not) (Drug & Device Law)
  • Justices Decline Pfizer's LA Court Fight, Hospital FCA Cases (Law360-$)
  • Takeda Wants Immediate Appeal Of Actos Order 'Uncertainty' (Law360-$)
  • Humira Buyers Say They've Proven AbbVie's 'Patent Thicket' (Law360-$)
  • Roche Hit With $137M Verdict For Infringing Lab Test Patents (Law360-$)
  • Boston Scientific Gets Sanctions Nixed In FCA Suit (Law360-$) (MassDevice)
Upcoming Meetings & Events Europe
  • MedTech Europe slams EU over lack of preparation for MDR/IVDR (MassDevice)
  • With 6 months until new EU medical device rules, what's the state of play? (MedtechDive)
  • National Assembly adopts historic amendment on transparency (Mediapart)
  • Russian drugmaker to receive compulsory license for Pfizer’s drug (Pharmaletter-$)
  • Ireland Relaxes Stance On Biosimilar Switching (Pink Sheet-$)
  • Merck’s KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy (Press)
  • Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) (Press)
  • Japan's Kyowa Kirin reorganizes quality responsibilities (Fierce)
  • Booster dose for Indian medical device makers (Economic Times)
  • Ceiling price of drugs should be fixed by giving extra margin to traders on all category of drugs: AIOCD urges NPPA (Pharmabiz)
  • Glenmark Pharma gets USFDA nod for diabetes management drug (Economic Times)
  • Indoco Remedies receives EIR from USFDA (Economic Times)
  • US health regulator finds Silvassa unit non-compliant with CGMP: Ipca Labs (Economic Times)
  • Knight and TherapeuticsMD Announce Filing of New Drug Submission for BIJUVA® in Canada (Press)
  • TGA response to federal court decision on urogynaecological mesh class action (TGA)
  • Update to listed medicine ingredients in November 2019 (TGA)
Other International
  • New WHO Public Inspection Report (WHOPIR) published (WHO)
  • Revised Appendix for Bioequivalence Trial Information (BTIF) (WHO)
General Health & Other Interesting Articles
  • Cannabis tied to severe heart attack risk in younger adults (Reuters)
  • How Much Should Big Tech Know About Our Personal Health Data And History? (NPR)
  • Health Officials in “Cancer Alley” Will Study if Living Near a Controversial Chemical Plant Causes Cancer (ProPublica)
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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