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Regulatory Focus™ > News Articles > 2019 > 12 > Recon: Drugmakers Cut Prices to Make China’s Reimbursement List; Baxter Buys Sanofi’s Seprafilm for

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

Posted 02 December 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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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In Focus: International
  • 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 $1 a Day (NYTimes)
  • Two Ebola treatments yield ‘substantial decrease’ in mortality, landmark trial shows (STAT) (NEJM)
  • EU allocates €50 million to fight Ebola and malnutrition in the Democratic Republic of Congo (EC)
  • Fatal attacks on Congo clinics risk resurgence of Ebola epidemic (Reuters 1, 2)
Pharmaceuticals & Biotechnology
  • Innovative finance schemes increase access to medicine (Financial Times)
  • US biotech M&A: gene genies (Financial Times)
  • What to Consider Before Trading Your Health Data for Cash (NYTimes)
  • Clarifying the Meaning of Clinically Meaningful Benefit in Clinical Research (JAMA)
  • This invite-only club is grooming new biotech CEOs — and helping make them less lonely, too (STAT)
  • Top Biogen scientist explains why he’s confident in company’s drug for Alzheimer’s (STAT)
  • Where BPCIA Issues Stand As FDA Approves 25th Biosimilar (Law360-$)
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Other International
  • 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)
General Health & Other Interesting Articles
  • M.R.I.s Can Better Detect Cancer in Women With Dense Breasts, Study Finds (NYTimes)
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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