Posted 27 April 2021 | By Michael Mezher 

Recon: HHS moves to expand buprenorphine treatment; Lilly misses on profit as COVID antibody demand wanes

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Eli Lilly profit misses as vaccines sap US demand for COVID-19 drugs (Reuters) (STAT) (Press)
  • Top US trade negotiator meets Pfizer, AstraZeneca execs on COVID-19 IP waiver (Reuters)
  • As opioid deaths surge, Biden team moves to make buprenorphine treatment mainstream (NPR) (HHS)
  • Bio­gen re­vers­es course on com­pas­sion­ate use for ALS drug tofersen with plans to open pro­gram in Ju­ly (Endpoints)
  • The most promising coronavirus vaccine you’ve never heard of (Politico)
  • Democrats brace for a drug pricing fight (Politico)

In Focus: International

  • India expects biggest share of US doses of AstraZeneca vaccine -govt sources (Reuters)
  • Factory troubles slow US move to share AstraZeneca vaccines (FT)
  • Novartis pushes back UK cholesterol study's end to 2026 on COVID disruption (Reuters)
  • Novartis warns of pandemic delay in cancer diagnoses (FT)
  • Novartis CEO says could boost CureVac vaccine production, if needed (Reuters)
  • Merck taps five Indian drugmakers to expand COVID-19 drug production (Reuters)
  • Italy judge sends Bayer, Novartis to trial in drugs fraud probe – sources (Reuters)
  • EU lawmakers debate Brexit accord before decisive vote (Reuters)

Coronavirus Pandemic

  • WHO steps up aid to India to stem COVID surge (Reuters)
  • Gilead to ship 450,000 remdesivir vials to India as COVID-19 cases surge (Reuters)
  • HHS secretary: ‘A lot of folks would listen’ if Trump made vaccine PSA (Politico)
  • Some Russians get extra COVID-19 shots, Sputnik V developers say no need (Reuters)
  • Egypt approves China's Sinovac coronavirus vaccine for emergency use (Reuters)

Pharma & Biotech

  • Novartis Financial Results – Q1 2021 (Press)
  • Public Web Conference Organised by the ICH E6(R3) EWG (ICH)
  • TGA issues warning about unlawful advertising of listed medicines (TGA)
  • US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long (Pink Sheet)
  • Big innovation shift to small pharma? Rookies grab lead in annual poll—and look to stay put (Fierce)
  • Global Therapeutics fined $119,880 for alleged unlawful advertising of complementary medicines (TGA)
  • Astellas takes $540M impairment charge over Audentes' gene therapy trial hold (Fierce)
  • A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response (FDA)
  • Eli Lil­ly aban­dons its plans to pitch its block­buster con­tender mirik­izum­ab for pso­ri­a­sis af­ter siz­ing up heavy­weight ri­vals (Endpoints)
  • Arch On­col­o­gy thinks it can stand out in the red-hot CD47 field, and it's tak­ing $105M in new cash to prove (Endpoints)
  • X-Bi­otix sus­pends R&D ef­forts amid dearth of fi­nanc­ing for an­tibi­otics re­search; Ver­tex picks a pain drug for mid-stage stud­ies (Endpoints)
  • The Car­lyle Group shells out $435M for con­trol­ling stake in vac­cine, gene ther­a­py ser­vices com­pa­ny (Endpoints)
  • Loxo founder Josh Bilenker, No­var­tis on­col­o­gy leader Jeff En­gel­man join forces to de­but can­cer R&D play­er (Endpoints)
  • Zymergen Ready for Prime Time after $530M IPO (GEN)
  • Af­ter fac­ing a 16-month so­journ dur­ing Covid to over­come a stun­ning CRL, lit­tle En­zy­vant says it's back on track — ex­pects mar­ket­ing de­ci­sion lat­er this year (Endpoints)
  • Es­pe­ri­on's strug­gling-to-mar­ket, would-be block­buster finds fresh in­fu­sion of cash (Endpoints)
  • Pa­tient deaths force Astel­las to write off $540M of their $3B gene ther­a­py buy­out as time­line grows and tar­get group shrinks (Endpoints)
  • Bio­gen's Michel Vounatsos takes home $18.7M in pay as the com­pa­ny bat­tles to take ad­u­canum­ab to mar­ket (Endpoints)

    EMA PRIME status granted for Vertex, CRISPR Therapeutics’ gene therapy CTX001 (PharmaTimes)
  • Chiesi's Raxone recommended for use within NHS Wales (PharmaTimes)

Medtech

  • Commission Optimistic Over EU MDR Readiness While Others See A Flawed System (MedtechInsight)
  • Abbott, Quest look to post-pandemic home testing beyond COVID-19 (MedtechDive)
  • Verily, LivaNova kick off study of nerve stimulation for treatment-resistant depression (Fierce)
  • COVID test maker Innova picks up Los Angeles-based N95 outfit (Fierce)
  • Not So Fast: FDA Announces End Of QUIK 510(k) Pilot (MedtechInsight)

Government, Regulatory & Legal

  • US Supreme Court Looks At Inventor Rights In Minerva-Hologic Dispute (MedtechInsight)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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