Recon: Trump Administration’s $2.5B Coronavirus Ask Faces Criticism From Both Parties

• White House seeks $2.5B for coronavirus, but Pelosi says that's not enough (NBC) (Reuters)
• Trump officials clash with senators over coronavirus response (Politico 1, 2)
• Tired of delays, US labs ask FDA to develop their own coronavirus tests (Reuters)
• US plans trial of Gilead coronavirus drug remdesivir (CNBC) (NIH)
• ICER appears to have a change of heart on new acute migraine therapies (Endpoints) (STAT)
• Biogen touts new evidence from the gene therapy company it wagered $800M on (Endpoints)
• Bicycle Therapeutics takes Genentech on an up to $2B immuno-oncology ride (Endpoints) (Press)
• Mallinckrodt Nets Government Support for $1.6 Billion Opioid Deal (WSJ) (Endpoints) (Law360-$)
• Moderna surges after first coronavirus vaccine sent for testing (Financial Times) (Endpoints) (Press)
• FDA approves first generic of ProAir HFA (FDA) (Fierce) (Press)
• Senate Republican gets on board with government drug price negotiations (Politico)
• Apple and J&J team up on new study to see if Apple Watch can reduce risk of stroke (CNBC)

• WHO tells countries to prepare for coronavirus pandemic, but insists it’s too soon to make that call (STAT) (NYTimes)
• South Korea's Moon says situation 'very grave' as mass virus tests get going (Reuters)
• Italy's PM Conte says impact of coronavirus on economy could be 'very strong' (Reuters)
• EU-UK relations: Council gives go-ahead for talks to start and adopts negotiating directives (EU Council)
• UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System (Xconomy)
• Novartis launches review into safety of eye drug Beovu (Reuters) (STAT) (Endpoints)
• AstraZeneca, still in asset-sale mode, hands off most global rights for constipation med Movantik (Fierce) (Press)
• Scotland's life sciences sector on track to break $8 billion by 2025 (Pharmafile)

• Novartis and DNDi to collaborate on the development of a new oral drug to treat visceral leishmaniasis (DNDi)
• Akili hopes the FDA pays attention (Evaluate)
• Google research suggests efforts to anonymize patient data aren’t foolproof (STAT)
• Most adults don’t need booster vaccinations for tetanus and diphtheria, new study concludes (STAT)
• Keeping up regular AMD treatment visits tied to less vision loss over time (Reuters)
• Kahr raises $18M to test CD47 drug with Roche's Tecentriq (Fierce)
• Real World Evidence - From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies (FDA)
• SoftBank's newest, $165M biotech investment looks for infectious traces in the blood (Endpoints)
• Steba’s Tookad: US FDA Panel To Weigh Novel Endpoints, Missing Data And Toxicities (Pink Sheet-$)
• Pending EO 12866 Regulatory Review (Reginfo)

• Roche’s Herceptin/Perjeta fixed-dose combo filed with FDA (PMLive) (Press)
• FDA accepts review to broaden GSK’s Zejula label (PMLive)
• Lysogene Receives FDA Fast Track Designation for LYS-SAF302 Gene Therapy in MPS IIIA (Press)
• IMV Inc. Announces Breakthrough Data from DeCidE1, its Ongoing Phase 2 Study of DPX-Survivac in Patients with Advanced Recurrent Ovarian Cancer (Press)
• IO Biotech Announces Positive Outcome of Interim Analysis of Phase 2 Randomized Trial in First Line Non-small Cell Lung Cancer (Press)
• FDA Grants IND Approval to Promising Anti-Cancer Agent Veyonda® (Press)

• FDA taps breakthrough device meant to prevent opioid overdose deaths (MedtechDive)
• 1st test for genetic condition tied to developmental delay wins FDA nod (MedtechDive)
• Agenda for Quarterly Meeting on MDUFA IV (FY 2018-2022) (FDA)
• Fresenius to launch a mechanical ventilators alternative in U.S. (MassDevice)
• Medtronic names its first chief inclusion and diversity officer (MassDevice)
• Mammograms not helpful in women 75 and older, study finds (Reuters)
• Luminex Submits Verigene II Respiratory Assay for FDA Clearance (Genomeweb)
• Streck Antibiotic Resistance Kits Receive CE Mark (Genomeweb)
• Co-Diagnostics SARS-CoV-2 Assay Garners CE Mark (Genomeweb)
• Orthofix Announces Support for Continued FDA Class III Designation for Bone Growth Stimulators to Ensure Patient Safety and Therapy Efficacy (Press)

• Review of the FY2021 Budget Request for HHS (Senate Appropriations)
• A psychiatrist was found guilty of distributing 1,200 painkillers after opioid task force bust (Washington Post)
• Purdue Pharma launches $23.8 million ad campaign on filing opioid claims against company (The Hill)
• A Local City Takes on Pharma (Harvard Bill of Health)
• Never Too Much of A Good Thing (Drug & Device Law)
• PTAB Won't Review 2 More HHS HIV-Prevention Patents (Law360-$)
• Genzyme Medical Device Suit Heads To Mass. High Court (Law360-$)

• FDA Advisory Committee Calendar
• Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 26 February 2020

• Medicines that cannot be parallel exported from the UK (MHRA)
• All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007) (MHRA)
• Class 4 Medicines Defect Information: Memantine 10mg Film-Coated Tablets, PL 20416/0260, (EL (20)A/11) (MHRA)

• Almirall announces plans for Seysara in China (PharmaLetter-$)

• NPPA tells chief secys to keep tabs on API availability (Economic Times)
• CDSCO directs state DCs to give BA/BE approvals for export within 15 days as per new rules (Pharmabiz)

• China's Hubei sees rise in new coronavirus cases as infections slow in other provinces (Reuters)
• US CDC confirms 53 coronavirus cases, including repatriated citizens (Reuters)
• Seventh Italian dies from coronavirus in Europe's worst flare-up (Reuters)
• China bans trade, consumption of wild animals due to coronavirus (Reuters)
• In the race for coronavirus vaccines, don’t leave pregnant women behind (STAT)
• First US Covid-19 trials set to get underway in Nebraska and Washington, backed by NIH (Endpoints)
• European pharmaceutical industry response to coronavirus (EFPIA)
• Iran's coronavirus death toll rises to 16 as worries deepen (Reuters)
• Canary Islands hotel under lockdown after coronavirus case - El Pais (Reuters)
• Kuwait reports three new cases of coronavirus, raising total to eight (Reuters)
• Fourth passenger from cruise ship dies in Japan – NHK (Reuters)
• All 16 of Vietnam's coronavirus sufferers cured (Reuters)
• Thailand reports two new virus cases, bringing total to 37 (Reuters)

• South African HIV carriers bullied before giving birth to accept sterilization (Reuters)

• Increasing numbers of older Baby Boomers are using marijuana: study (Reuters)