Recon: Drugmakers Cut Prices to Make China’s Reimbursement List; Baxter Buys Sanofi’s Seprafilm for $350M

• Baxter picks up Sanofi's Seprafilm adhesion barrier for $350M (MedtechDive) (Endpoints)
• Lexicon Pharma shares plummet after FDA denies appeal against drug rejection (Reuters)
• Incyte claims FDA priority review for bile duct cancer drug (PMLive)
• AstraZeneca's Imfinzi gets speedy FDA review for small cell lung cancer (Reuters) (PMLive)
• Merck’s Keytruda significantly extends life in some prostate cancer patients (PMLive)
• C&EN’s Year in Pharma 2019 (C&EN)
• Novartis Deal for Heart Drug Hinges on Succeeding Where Rivals Struggle (WSJ) (Financial Times)
• Biocon, Mylan launch Trastuzumab biosimilar in US (Economic Times) (Center for Biosimilars) (Press)
• Biotech VC Down 20% in US as Policies Drive Away Foreign Investors, BIO (Xconomy)
• Dexcom server outage rocks Type 1 diabetes community (MedtechDive) (WSJ)
• Senate quicksand engulfs a bipartisan plan that Trump backs (Politico)
• Senate HELP Committee to Vote to Advance Hahn Nomination Tuesday (Senate HELP)

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• Global drugmakers strike deal to slash prices in China (Financial Times) (PMLive) (Endpoints)
• China to use drug bulk-buy program to close price gap (Reuters)
• Novartis's $90 million Swiss factory to help solve cell therapy bottleneck (Reuters)
• Morphosys CFO says tafasitamab drug sales potential above $1 billion: magazine (Reuters)
• Innovative finance schemes increase access to medicine (Financial Times)
• UK regulator seeks to reinstate £90m fine against Pfizer and Flynn (Financial Times) (PMLive)
• Pfizer’s Ibrance approved by NICE, to be added to the Cancer Drugs Fund (Pharmafile)
• Celltrion bags EU approval for Remsima SC off back of new data (PharmaTimes)
• New Strawberry-Flavored HIV Drugs for Babies Are Offered at $1 a Day (NYTimes)
• Two Ebola treatments yield ‘substantial decrease’ in mortality, landmark trial shows (STAT) (NEJM)
• EU allocates €50 million to fight Ebola and malnutrition in the Democratic Republic of Congo (EC)
• Fatal attacks on Congo clinics risk resurgence of Ebola epidemic (Reuters 1, 2)

• Innovative finance schemes increase access to medicine (Financial Times)
• US biotech M&A: gene genies (Financial Times)
• What to Consider Before Trading Your Health Data for Cash (NYTimes)
• Clarifying the Meaning of Clinically Meaningful Benefit in Clinical Research (JAMA)
• This invite-only club is grooming new biotech CEOs — and helping make them less lonely, too (STAT)
• Top Biogen scientist explains why he’s confident in company’s drug for Alzheimer’s (STAT)
• Where BPCIA Issues Stand As FDA Approves 25th Biosimilar (Law360-$)
• ImmuPharma licenses lupus drug Lupuzor to Avion in the United States (Reuters)
• Analyst Brian Skorney goes grizzly on Biogen’s Alzheimer’s ‘hype,’ ‘fearmongering’ and ‘statistical malpractice’ (Endpoints) (Fierce)
• Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence (Economic Times)
• Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises (Pink Sheet-$)
• US FDA Thinking Small To Solve Big Shortages (Pink Sheet-$)
• Treating HIV-infected infants very early substantially improves health: study (Reuters)
• HIV Is Coming to Rural America (NYTimes)
• PrEParing to End the HIV Epidemic — California’s Route as a Road Map for the United States (NEJM)
• Differences Put Aside As ICH Finalizes Guide On Post Approval Changes (Pink Sheet-$)
• Head-to-head comparison finds three anti-seizure drugs equally effective for severe form of epilepsy (NIH)
• Baker Bros. places a $250M bet on a potential rival to Regeneron and Novartis — with a $1B-plus payoff on the line (Endpoints)
• Winning a North American client, WuXi Biologics aims to be top global vaccine supplier (PharmaLetter-$)
• Exclusive interview: Samsung Bioepis' Sang-Jin Pak on the rise of biosimilars (Pharmafile)
• Pfizer's retired NASH drug shown to reduce liver fat, inspiring new faith in the DGAT2 pathway (Endpoints)
• Numero quattro: Immunology experts at deal-focused IFM line up $55.5M for the next leg of their drug exploration journey (Endpoints)
• Agios taps Bristol-Myers vet Bruce Car to replace retiring CSO (Endpoints)
• Neurocrine is beefing up its pipeline, splurging $50M on rights to an epilepsy drug (Endpoints)
• They Gave Me Oxy. I Didn’t Want It. Now What? (NYTimes)
• An Analysis of Recent FDA Oncology Scientific Publications (The Oncologist)
• Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; AIMOVIG (FDA)

• AstraZeneca gains a speedy Imfinzi review in race to beat Roche on frontline SCLC (Endpoints)
• FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC) (Press)
• Positive phase III results for Roche’s satralizumab in neuromyelitis optica spectrum disorder published in the New England Journal of Medicine (Press)
• Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine (Press)
• The race to best treat a disease long confused with MS heats up with Roche's PhIII results (Endpoints)
• Epizyme Announces FDA Advisory Committee Meeting to Review Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma (Press) (FDA)
• Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (Press)
• Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements (Press)
• Oragenics, Inc. Announces Completion of Enrollment of Its Phase 2 Clinical Trial for AG013 in Oral Mucositis (Press)
• Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Erosive Esophagitis (Press)
• Knopp Biosciences and University of Leicester Announce Update on Planned Phase 2 Clinical Trial of Oral Dexpramipexole in Severe Eosinophilic Asthma (Press)
• Sensorion Announces Results From SENS-111 Phase 2b Trial in Acute Unilateral Vestibulopathy (Press)
• PellePharm Completes Enrollment of Pivotal Phase 3 Clinical Trial of Patidegib Topical Gel in Patients with Gorlin Syndrome (Press)
• Concert Pharmaceuticals Initiates CTP-692 Phase 2 Trial in Schizophrenia (Press)
• SK Life Science, Inc. Announces FDA Acceptance of IND Application for Anti-Epileptic Drug Candidate SKL24741 (Press)

• Intuitive gets FDA go-ahead for robotic system sealing instrument, power generator (MedtechDive)
• FDA approves TB test from Qiagen and DiaSorin (MedtechDive)
• FDA seeks public input on pediatric device applications including ways to minimize burden (MedtechDive)
• How GE Healthcare is investing in medtech innovation (MassDevice)
• EOS imaging RECEIVES U.S. FDA 510(K) CLEARANCE FOR EOSedge™ ITS NEW GENERATION INNOVATIVE IMAGING SYSTEM (Press)

• Battle inside Humphrey Building spills over (Politico)
• Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions (BigMoleculeWatch)
• Policymakers are taking the wrong approach to health care reform (STAT)
• Pelosi's plan a 'nuclear winter' for pharma, analyst says (Fierce)
• United States v. Gilead Sciences, Inc. (Patent Docs)
• Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019) (Patent Docs)
• Amazon lets doctors record your conversations and put them in your medical files (CNBC)
• Picky MDL Plaintiff Gets The Same Discovery Plate As Everyone Else (Drug & Device Law)
• Double dipping in an NIH loan repayment program, and using undersea cables as seismic sensors (Science)
• On The Receiving End (Drug & Device Law)
• FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process (FDA Law Blog)
• Sun Pharma gets partial relief from US court in litigation involving three generic drugs (Economic Times)
• Which Drug Prices Should Medicare Negotiate? A “Too Little” or “Too Late” Approach (NEJM)
• Advancing Legislation on Drug Pricing — Is There a Path Forward? (NEJM)
• FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health (FDA)

• FDA Advisory Committee Calendar
• ‘Regulatory science to 2025’: live broadcast of post-consultation workshop on veterinary medicines – 5-6 December 2019
• Oncologic Drugs Advisory Committee; Notice of Meeting – 18 December 2019

• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019 (EMA)
• MDR watch: Compliance deadline for upclassified Class I medical devices pushed to 2024? (Emergo)
• MHRA phase I accreditation scheme (MHRA)
• EU Needs More Teamwork On Drug Pricing & Access (Pink Sheet-$)
• Europe's Off-Patent Industry Seeks Action On Shortages (Pink Sheet-$)
• EU Ministers To Debate Pharma ‘Market Failures And High Prices’ (Pink Sheet-$)
• European pharma industry objects to proposed HTA system (PharmaLetter-$)
• Dr Richard Torbett is named as the new Chief Executive of the ABPI (Pharmafile) (ABPI)

• China reports fourth case of plague this month (Reuters)
• Japan Approves Genetic Testing For Breast Cancer Treatment (Forbes)

• Volume with low cost is Biocon Biologics’ big plan (Economic Times)
• Study shows widespread bribery in Indian pharmaceutical industry (Pharmafile)
• Roche India head Lara Bezerra set to exit (Economic Times)
• Pharma Inc agrees to cap margins on non-price control drugs at 30% (Economic Times)

• Notice of final decisions to amend (or not amend) the current Poisons Standard, November 2019 (TGA)
• Submissions received: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices (TGA)
• Safety review of coumarin in topical listed medicines (TGA)
• Progress report: Australian Government response to the Senate Community Affairs References Committee report (TGA)
• Delegate-only final decisions and reasons: NCEs, November 2019 (TGA)
• Update on safety and performance concerns of suspended breast implants (TGA)
• Changes to the label warning statement requirements for menthol & methyl salicylate (TGA)
• High-moderate risk changes to permissible ingredients - Andrographis paniculate (TGA)
• Outcomes: Changes to permissible ingredients - Low-negligible risk (TGA)

• Notice: Update to Clinical Trial Site Information Form (Health Canada)

• Samoa in Christmas lockdown as measles deaths top 50 (Reuters)
• New WHO Public Inspection Reports (WHOPIRs) published (WHO)
• The World Health Organization Prequalification Program and Clinical Pharmacology in 2030 (ASCPT)

• M.R.I.s Can Better Detect Cancer in Women With Dense Breasts, Study Finds (NYTimes)