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

• 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)

• 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 5^th 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)

• 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)

• 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)

• 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)

• 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-$)

• FDA Advisory Committee Calendar

• 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)

• Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations? (Scrip-$)

• Illegal cancer drugs from Bangladesh flood local market (Economic Times)
• Frequent FDA inspections slow down Indian pharma exports, says GV Prasad (Economic Times)

• Breast implants: Things to consider before having the procedure (TGA)
• Prescription opioids: Information for consumers (TGA)

• Samoa declares state of emergency as measles spreads across Pacific (Reuters)

• Stanford’s new hospital is brimming with futuristic tech. Will it help save money — or drive up costs? (STAT)