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Regulatory Focus™ > News Articles > 2019 > 11 > Recon: Recipharm to Buy Consort Medical for £505M; FTC Approves BMS-Celgene Merger

Recon: Recipharm to Buy Consort Medical for £505M; FTC Approves BMS-Celgene Merger

Posted 18 November 2019 | By Michael Mezher 

Recon: Recipharm to Buy Consort Medical for £505M; FTC Approves BMS-Celgene Merger

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • BMS wins antitrust approval to buy Celgene, must divest psoriasis drug (Reuters) (PMLive) (FTC)
  • Novartis sickle-cell drug gets FDA approval  (Reuters) (Endpoints) (Fierce) (FDA) (Press)
  • Trump says US states will be able to buy prescription drugs abroad (Reuters)
  • FDA nominee to face questions on issues from vaping to salmon (Roll Call)
  • Oklahoma judge reduces J&J opioid payout to $465M (Reuters) (NYTimes)
  • Stents no better than drugs for many heart patients: US study (Reuters) (PBS)
  • FDA clears Pentax's duodenoscope designed to reduce need for disinfection (Reuters) (FDA)
  • Pfizer gets biosimilar approved for Humira, setting up competition — in 2023 (Endpoints) (Press) (FDA)
  • Merck and Bayer's heart drug meets main goal of late-stage study (Reuters) (Endpoints) (Press)
  • Drug cost legislation gets a push from White House (AP)
In Focus: International
  • Sweden's Recipharm Agrees to Buy Britain's Consort Medical for £505M (NYTimes) (Reuters)
  • Alkermes buys Rodin Therapeutics for up to $950 million, giving it possible avenue for growth  (STAT) (Endpoints) (LifeSciVC)
  • Top 10 Pharma Companies of 2019 (GEN)
  • NHS running short of dozens of lifesaving medicines (The Guardian)
  • China to launch inspection on use of illegal African swine fever vaccines (Reuters)
  • Short sellers highlight bubble fears in South Korea biotech (Financial Times)
  • Novartis switches gears in Shanghai from research to drug development (Reuters) (Endpoints)
  • Dutch diagnostics player Qiagen confirms buyout talks following report of Thermo Fisher's interest (Endpoints)
  • Dicerna links up with Novo in its 5th liver-focused R&D deal (BioPharmaDive) (Endpoints) (Press)
  • Congo president says Ebola outbreak should be over this year (Reuters)
  • Biosimilars Make Progress in the Canadian Market, but Stakeholders See More Work Ahead (Center for Biosimilars)
Pharmaceuticals & Biotechnology
  • Sharing clinical trial data: lessons from the YODA Project (STAT)
  • BeiGene prices lymphoma drug at $12,935 for a 30-day supply (Reuters)
  • GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions (Focus)
  • FDA’s OPDP Sends Untitled Letter Over Promos for Unapproved Brain Cancer Treatment (Focus)
  • FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports (Focus)
  • FDA Finalizes Smallpox Drug Development Guidance (Focus)
  • Eyeing one of the first RNAi therapies and cholesterol blockbuster, MedCo shows detailed inclisiran data (Endpoints)
  • After late-stage miss, Novartis touts another Entresto analysis to convince the FDA to expand the blockbuster's label (Endpoints) (Fierce)
  • In a rare political move, prominent biotech venture capitalists speak out against Pelosi’s drug pricing bill (STAT)
  • CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach (Pink Sheet-$)
  • What's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships (BioPharmaDive)
  • How The Oral Polio Vaccine Can Cause Polio (NPR)
  • Pediatric drug trial finds benefit in teens with heart defect (NIH)
  • SOPP 8116: Use of Electronic Signatures for Regulatory Documents (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • A new approach to treating schizophrenia delivers positive results in mid-stage trial (STAT) (Endpoints) (Press)
  • Mezzion Pharma announces the presentation of the FUEL Trial data at the American Heart Association Meeting in Philadelphia (Press)
  • Levo Therapeutics Receives Fast Track Designation From FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome (Press)
  • Axial Biotherapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial Evaluating AB-2004 in Patients with Autism Spectrum Disorder (Press)
  • Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-301 in Patients with ASPH-Positive Head and Neck Cancer (Press)
  • AVEO Announces Presentation of Updated OS and Subgroup Data from Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma (Press)
  • Bempedoic Acid Lowers LDL-Cholesterol without Adversely Impacting Glycaemic Control in Pooled Analyses of Phase 3 Trials Presented at the American Heart Association 2019 Scientific Sessions (Press)
  • Triple-Gene Presented Preliminary Phase 1 Trial Data of Investigational Multigenic Therapeutic Candidate INXN‑4001 for Treatment of Heart Failure at American Heart Association Annual Meeting (Press)
  • RemeGen, Ltd. Announces Positive Results from Phase IIb Clinical Trial in Systemic Lupus Erythematosus (Press)
  • AHA: AstraZeneca's Farxiga outcomes data look even better in patients without diabetes (Fierce) (Press)
  • AHA: Johnson & Johnson, Bayer still looking for answers in aborted Xarelto study (Fierce)
  • AHA: Amgen's Repatha tied to greater risk reduction in high-risk heart attack patients (Fierce)
  • AHA: Analysis counters concerns about Amgen heart failure drug (Fierce)
  • AHA: AstraZeneca's Brilinta linked to less bleeding solo than as an aspirin add-on (Fierce)
  • AHA: MedCo's PCSK9 rival inclisiran hits LDL (Fierce)
  • AHA: Lilly, Boehringer's Jardiance cuts CV hospitalizations over rival diabetes meds (Fierce)
  • AHA: Caladrius single injection helps heart disease that hits women the hardest (Fierce)
  • Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Press)
Medical Devices
  • A Blind Man Sees His Birthday Candles Again, Thanks to a Bionic Eye (OneZero)
  • FDA Advisers Hear About Problems, Research Needs With Metal Implants (Medpage)
  • Device Implants Need Better Labels, Advisers Tell FDA (Medpage)
  • Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data (Press)
  • FDA approves first contact lens indicated to slow the progression of nearsightedness in children (Press)
  • Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop (FDA)
  • Edwards issues recall for Pascal guide sheaths (MassDevice)
US: Assorted & Government
  • NYC comptroller aims to 'clawback' pay of HIV pharma executives (NBC)
  • Trump Retreats From Flavor Ban for E-Cigarettes (NYTimes) (Politico)
  • Commentary: Collins’ bill fails to address root cause of drug shortages (Press Herald)
  • Amazon adds new ‘Amazon Pharmacy’ branding to PillPack and promotes its CEO (CNBC)
  • Calling for federal action, watchdog says there’s no evidence dietary supplements for infertility help women get pregnant (STAT)
  • A new bill would let more doctors prescribe addiction treatments without waiting for insurers’ permission (STAT)
  • Elizabeth Warren Vows to Expand Health Coverage in First 100 Days (NYTimes)
  • In states with restrictive abortion laws, women seek online options (Reuters)
  • The Theranos Saga Continues: Court Requires Government to Produce Documents (FDA Law Blog)
  • Limits to Duty 2.0 − On Product Manufacturers Supervising Doctors (Drug & Device Law)
  • Hospira Infringed 2 Valid Par Adrenalin Patents, Judge Says (Law360-$)
Upcoming Meetings & Events Europe
  • EMA Lands at Permanent Amsterdam Building as CHMP Recommends 5 New Medicines for Approval (Focus)
  • EC Considers Amending Provision on Duplicate MAAs for Biologics (Focus)
  • Ex ante publicity of a negotiated procedure (EMA)
  • EMA Recharges Role In Non-EU Drug Approvals (Pink Sheet-$)
  • Class 3 Medicines Recall: Folic Acid Tablets BP 5mg, PL 0142/5522, (EL(19)A/35) (MHRA)
Asia
  • Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations? (Scrip-$)
India
  • Illegal cancer drugs from Bangladesh flood local market (Economic Times)
  • Frequent FDA inspections slow down Indian pharma exports, says GV Prasad (Economic Times)
Australia
  • Breast implants: Things to consider before having the procedure (TGA)
  • Prescription opioids: Information for consumers (TGA)
Other International
  • Samoa declares state of emergency as measles spreads across Pacific (Reuters)
General Health & Other Interesting Articles
  • Stanford’s new hospital is brimming with futuristic tech. Will it help save money — or drive up costs? (STAT)
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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