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Pfizer and BioNTech move on COVID-19 vaccine work apace

As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their…



  • BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines

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Akebia soars on positive Ph III trial results for vadadustat

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…



  • Akebia Therapeutics/Biotechnology/Drug Trial/Nephrology and Hepatology/Research/USA/vadadustat

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ALK Abello outperforms expectations in strong 1st-qtr

Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner…



  • Acarizax/ALK Abello/Denmark/Financial/Immunologicals/Itulazax/Pharmaceutical

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Portola agrees to takeover bid from Alexion

Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive…



  • Alexion Pharmaceuticals/AndexXa/Anticoagulants/Biotechnology/Cardio-vascular/Companies
  • mergers and acquisitions/Hematology/Ondexxya/Portola Pharmaceuticals/USA

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FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…



  • AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA

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Stockpiling spurs sales at Novo Nordisk in first quarter

Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations…



  • Biotechnology/Denmark/Diabetes/Financial/Management/Novo Nordisk/Ozempic/Research/Rybelsus/Tresiba/USA/Victoza

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Otezla’s impact shown in milder psoriasis

Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…



  • Amgen/Biotechnology/Dermatologicals/Drug Trial/Inflammatory diseases/Otezla/Research/USA

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An important option in the fight against antimicrobial resistance

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA

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BRIEF—GSK completes sale of nutrition brands for £3.4 billion

GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products…



  • Companies
  • mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK

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First targeted therapy for aggressive form of lung cancer approved by FDA

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…



  • Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA

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Growth forecast for drug delivery systems market

COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems…



  • Anti-virals/Antibiotics and Infectious diseases/Asia Pacific/Biotechnology/Coronavirus/Drug delivery systems/Focus On/Healthcare/Markets & Marketing/Oncology/USA

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Dr Reddy's gets FDA nod for migraine drug Elyxyb

Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker…



  • Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA

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BetterLife Pharma inks licensing deal for AntiCovir

Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement…



  • Altum Pharmaceuticals/Anti-virals/AntiCovir/BetterLife Pharma/Biotechnology/Canada/Coronavirus/Deals/Focus On/Licensing/Research

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Japan grants ‘exceptional’ approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

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Recordati 1st-qtr revenues rise 12% as income leaps more than 20%

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…



  • Financial/Italy/Pharmaceutical/Recordati/Signifor

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FDA backs Retevmo for certain lung and thyroid cancers

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…



  • Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA

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jCyte out-licenses rare vision disorder treatment for $252 million

US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…



  • Biotechnology/Deals/Japan/jCell/jCyte Inc/Licensing/Ophthalmics/Rare diseases/Santen/USA/Vision disorder

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AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.




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Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.




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Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.




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With the world waiting, Roche socks $459M into COVID-19 antibody test production

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 




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Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.




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AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 




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Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says

After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. 




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AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes

AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. 




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Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials

German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.




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Amgen ramps up Otezla expansion effort with positive data in mild psoriasis

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.




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Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.




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Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir

The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.




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Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.




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GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.




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Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 




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Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 




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Gilead hit with Iranian cyberattack for role in COVID-19 response: report

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.




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U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths

The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.




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Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.




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China reports one new coronavirus case, 15 asymptomatic cases

China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.




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Thailand reports four new coronavirus cases, one new death

Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January.




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China to reform disease prevention system

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.




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Singapore reports 753 new coronavirus cases, taking total to 22,460

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.




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Russia records more than 10,000 new coronavirus cases in past day

Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.




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Philippines' coronavirus deaths breach 700

The Philippines' health ministry reported on Saturday that coronavirus deaths have reached more than 700.




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Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.




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Indonesia reports 533 new COVID-19 cases, biggest in a day

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.




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Malaysia reports 54 new coronavirus cases and one new death

Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.




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Slovakia records no new coronavirus cases for first time since March 10

Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed.




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Tijuana coronavirus death rate soars after hospital outbreaks

The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards.




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New York governor says 5-year old died from rare COVID-related complications

A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.




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Portugal's low-income households struggle to survive pandemic

One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday.




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Factbox: Latest on the worldwide spread of the coronavirus

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.