Recon: CureVac starts trial of COVID-19 vaccine; Generic drugmakers to boost dexamethasone output

• A Mad Scramble to Stock Millions of Malaria Pills, Likely for Nothing (NYTimes)
• BioMarin’s hemophilia gene therapy continues to prevent bleeding at four years (STAT) (Endpoints)
• “Fast-Tracking” a Coronavirus Vaccine Sounds Great. It’s Not That Simple. (ProPublica 1, 2)
• Show me the data: US doctors skeptical of reported COVID breakthrough (Reuters)
• US appeals court rejects rule requiring drug prices in TV ads (Reuters) (Law360)
• Missing Data: One Long-Term Lesson From US FDA Action On Hydroxychloroquine (Pink Sheet)
• Neurocrine bets $2B on Takeda's psychiatry drugs (BioPharmaDive)

• EU calls for global alliance to buy COVID-19 vaccines up front (Reuters)
• CureVac starts trial of experimental coronavirus vaccine, eyes launch next year (Reuters 1, 2, 3)
• Germany not planning to take further biotech stakes after CureVac move (Reuters)
• Pharma groups to ramp up output of virus drug dexamethasone (Financial Times)
• UK continuing drug trials to improve on COVID-19 steroid treatment (Reuters)
• WHO moves to update COVID-19 guidance after 'great news' in drug study (Reuters) (WHO)
• WHO drops hydroxychloroquine from Covid-19 clinical trial (STAT)
• MHRA suspends recruitment to COVID-19 hydroxychloroquine trials (MHRA)
• Israel approves remdesivir drug for COVID-19 treatment (Reuters)
• EMA Says Big Data Network Is A ‘Priority’ Project (Pink Sheet)
• Final NICE green light for Janssen's Stelara in UC (PharmaTimes)

• The long road to a Covid-19 vaccine (Financial Times)
• ‘We’ve got to be able to move more quickly.’ The pandemic reality of COVID-19 clinical trials (Science)
• Belgium had the worst response to the coronavirus crisis among OECD countries, EIU says (CNBC)
• Immune status could determine efficacy of COVID-19 therapies (Nature)
• PTC Therapeutics taps experimental cancer drug for new COVID-19 trial (Fierce)
• Japanese researchers confirm coronavirus testing in sewers as possible outbreak warning system (Reuters)
• Verily's COVID-19 community testing project now reaches 130 cities nationwide (Fierce)
• Carlyle-backed Ortho Clinical gets U.S. funding for COVID-19 tests (Reuters)
• Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling (FDA)
• Coronavirus (COVID-19) Update: Daily Roundup June 16, 2020 (FDA)

• As quality concerns rise, FDA report shows Indian drug plants inspected more often — and had more problems (STAT)
• ADA: Merck, Pfizer's Steglatro rings up CV safety win but still lags heart-helping peers (Fierce)
• A new hope for Amarin? Vascepa generic settlement leaves analysts split on patent appeal success (Fierce)
• Lilly's Verzenio shows up Ibrance, hitting its goal in early breast cancer after Pfizer's drug faltered (Fierce)
• CAR-T cells, better known as cancer drugs, show promise against aging in lab mice (STAT)
• Avidity tops up IPO at $298M; Bristol Myers keeps a Celgene discovery pact alive (Endpoints)
• Amicus shares surge as Sanofi struggles to raise a cheer for mixed pivotal data for a PhIII contender — and analysts blow a raspberry (Endpoints)
• All in on IL-11, Frazier unveils latest startup with dual focus on fibrosis and cancer (Endpoints)
• A Bay Area upstart with legendary godfathers breaks cover, touting claims of a curative tech, unicorn status and a $300M plan to shoot for an approval (Endpoints)
• Dewpoint nabs ex-Sanofi CEO Brandicourt and Bayer VC chief Eckhardt for board (Endpoints)

• FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events (MedtechInsight)
• A Medical Device Maker Threatens iFixit Over Ventilator Repair Project (Vice)
• Thermo Fisher, MedRhythms gain breakthrough device designations (MedtechDive)
• Endologix stent graft tied to 5 deaths gets high-risk recall label from FDA (MedtechDive) (FDA)
• New procedures released for medical device registration in China (Emergo)
• Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016) (MHRA)

• Illumina Wins Bid To Block BGI Genomics' DNA Product Sales (Law360)
• Eagle Fights FDA's DC Circ. Bid To Undo Orphan Drug Win (Law360)