Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer

• Sage depression therapy fails much-awaited trial, stunning investors (Reuters) (STAT) (Endpoints) (Press)
• Eli Lilly to put Loxo executives in charge of new cancer research unit (Reuters) (STAT) (Press)
• Biogen to make case to skeptics for its controversial Alzheimer's drug (Reuters)
• Acadia Pharma's psychosis drug proven better than placebo in dementia patients (Reuters) (Press)
• GSK seeks FDA approval for investigational HIV treatment (Reuters)
• What side effects? Problems with medicines may be vastly underreported to the FDA (STAT)
• More than 100 small biotech CEOs sound off against Pelosi’s signature drug pricing bill (STAT)
• Pharma’s Take On The Pelosi Drug-Pricing Bill: Fair Warning Or Fearmongering? (KHN)
• House to vote next week on sweeping bill to lower drug prices (The Hill)
• FDA authorizes marketing of diagnostic that uses novel technology to detect MRSA bacteria (FDA)

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• Novartis CEO plans 80+ submissions for drug approvals through 2022 (Reuters) (PMLive) (Endpoints)
• Novartis R&D boss says doesn't see big opportunity in oral SMA therapy (Reuters)
• AstraZeneca-Merck Lynparza wins approval in China for ovarian cancer treatment (Reuters) (Press)
• Half a million Ebola vaccine doses to be stockpiled for emergency use (Reuters) (STAT)
• Measles toll in Congo exceeds 5,000, WHO says (Reuters)
• Samoa fights measles door-to-door in battle on anti-vaccination messages (Reuters)
• New typhoid fever vaccine protects young children (Reuters)

• As Alzheimer’s Conference Kicks Off, All Eyes Are on Biogen’s Drug (Xconomy)
• 20% Of Prescription Drugs Save Money, And Are Not Just Cost-Effective (Forbes)
• Rethinking drug design in the artificial intelligence era (Nature)
• Vivek Ramaswamy’s Enzyvant is hit with a CRL for manufacturing — delaying a new therapy for an ultra-rare killer (Endpoints)
• Thermo Fisher opens $90M viral vector manufacturing plant in Massachusetts (BioPharmaDive)
• Michael Ehlers teases plan to build the next 'signature' genetic medicine company with $75M from Apple Tree Partners (Endpoints)
• A biotech emerges from Deerfield's R&D donation plan (Endpoints)
• ANDA Approval Records Will End As US FDA Mops Up Backlog (Pink Sheet-$)
• US FDA Says Data Integrity Remains Challenging For API Manufacturers (Pink Sheet-$)
• IPO Benefits And Challenges For Early-Stage Biotech Cos. (Law360-$)
• RNAi agents score an approval and drive an acquisition (Nature)
• Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges (Pink Sheet-$)
• Once-a-Month Birth Control Pill? Experiment Works in Animals (AP) (Reuters)
• Drug curbs delusions, eases anger in Alzheimer's patients, researchers find (NBC)
• Daphne Koller's AI startup ends wide search for a data chief, tapping Stanford's Serafim Batzoglou for the job (Endpoints)
• Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin (FDA Law Blog)
• Has Physician Specialty Dispensing Peaked—And Should They Blame PBMs? (Drug Channels)
• Biocon sees a sweet spot with its affordable insulin in US (Economic Times)
• One of the Biggest Public Health Initiatives in History: PEPFAR and HIV (Harvard Bill of Health)

• Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine (Press)
• Aurinia soars as phase 3 lupus study hits primary endpoint (Fierce) (Endpoints) (Press)
• Revance Announces Publication of Pooled Results from Phase 3 Trials for Glabellar Lines in the Journal of the American Academy of Dermatology (Press)
• NeuClone Announces Positive Results from Phase I Study of Herceptin® (Trastuzumab) Biosimilar Candidate (Press)
• Samus Therapeutics Announces Presentation of PU-AD Phase 1 Data for Alzheimer's Disease at CTAD Congress (Press)
• Meissa Vaccines Receives FDA Clearance of IND Application for a Phase 1 Clinical Trial of MV-012-968 for Respiratory Syncytial Virus (Press)

• Edwards projects up to $5B in 2020 sales (MedtechDive)
• 6 Experimental Alzheimer’s Disease Diagnostics Projects Get Funding Boost (Xconomy)
• Israeli fingerprick blood testing company gets FDA clearance for CBC analyzer (MedCity)
• Boston Scientific afib device effective in reducing stroke (MedtechDive)
• Vicarious' surgical robot gets FDA breakthrough status (MedtechDive)
• FDA grades new Medtronic SynchroMed II recall as Class I event (MedtechDive)
• Tips for a successful FDA Human Factors meeting, Part One: Preparing for the meeting (Emergo)
• MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management (Press)

• How next week's universal coverage hearing is shaping up (Politico)
• J&J’s Ethicon gets to substitute 20 new claims on surgical stapler patent (MassDevice)
• Jury Told 'Whole Field' Knows Kite Infringed Juno's Patent (Law360-$)
• Judge Holds Decision On Purdue Pharma CEO Bonus (Law360-$)
• PTAB Rejects Agilent's Challenge Of Testing Kit Patent (Law360-$)

• FDA Advisory Committee Calendar
• Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – 14 January 2020
• Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – 15 January 2020

• Eudamed delayed, but MDR not delayed – now what? (MedicalDevicesLegal)
• Future Unclear For EU Mandatory Joint Clinical Assessment Plans (Pink Sheet-$)
• Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40) (MHRA)
• Natus gold cup electrodes and snap electrode leads – risk of electric shock (MHRA)
• Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma. (MHRA)

• Mankind Pharma launches drug for treatment of infertility in India (Economic Times)
• Zydus Cadila files NDA for Saroglitazar Magnesium (Economic Times)
• DCGI directs manufacturers to submit PSURs every six months for first two years for veterinary products in India (Pharmabiz)

• The American Health Care Industry Is Killing People (NYTimes)
• Hair Dyes and Straighteners May Raise Breast Cancer Risk for Black Women (NYTimes)
• Don’t call it the Freer/Sackler. Call it the National Museum of Asian Art. (Washington Post)