3

3M Drug Delivery Systems relaunches as Kindeva Drug Delivery

The launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners.




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Coronavirus Industry Impact Survey: Winners and Losers (Part 3)

Today is the final installment of our three-part investigation into the coronavirus’ ultimate impact on the drug channel.

Below, I examine expectations about how the coronavirus will affect the public’s perception of various industry participants. We explore what our survey respondents said about:
  • Pharmacies
  • Pharmaceutical manufacturers
  • Hospitals
  • Wholesalers
  • Pharmacy benefit managers and plan sponsors
  • Insurance companies.
In these early stages of this crisis, my crystal ball is as cloudy as yours. Let’s hope that the country will stabilize within a few months. I may then rerun the survey to determine how (if at all) everyone’s perspective has changed.
Read more »
        




3

Did Galileo Truly Say, 'And Yet It Moves'? A Modern Detective Story

An astrophysicist traces genealogy and art history to discover the origin of the famous motto

-- Read more on ScientificAmerican.com




3

Menopause Predisposes a Fifth of Women to Alzheimer's

Being female is a risk factor for Alzheimer’s. Why?

-- Read more on ScientificAmerican.com




3

Just How Dangerous Is the 'Murder Hornet'?

Its sting is excruciating to people, but it is a bigger threat to honeybees vital for agriculture

-- Read more on ScientificAmerican.com




3

People Don't Have to Succumb to Anxiety during This Pandemic

That emotion is natural in a situation like this, but there are ways to mitigate it

-- Read more on ScientificAmerican.com




3

'Breakthrough' COVID-19 Tests Are Currently Cheap, Fast--and Not Very Accurate

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com




3

We'll find a treatment for coronavirus – but drug companies will decide who gets it

Pharmaceutical giants will bury treatments in a thicket of patents, making them unaffordable to the world’s poorest

How will the Covid-19 pandemic end? According to conventional wisdom, the crisis may ease in a few months, when some of the antiviral medicines on trial succeed. In a few years’ time, when a vaccine becomes available, we may eradicate the virus altogether.

Yet it’s unlikely that this is how the pandemic will actually play out. Although there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents – and pharmaceutical companies will ultimately make the decisions about who lives and who dies.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

Continue reading...




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We're desperate for a coronavirus cure, but at what cost to the human guinea pigs? | Kenan Malik

Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

• Coronavirus latest updates

• See all our coronavirus coverage

Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

Continue reading...




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World's stock markets soar on coronavirus treatment hopes

Investors shrug off US growth gloom after promising data from remdesivir drug trial

Shares have soared on the world’s stock markets after investors shrugged off a deep slump in the US economy and pinned their hopes on a possible breakthrough in treatment for Covid-19.

Despite news that the longest expansion in US history came to an abrupt end in the first three months of 2020, financial markets were buoyed by an update from the American biopharma company Gilead Sciences on its experimental drug remdesivir.

Continue reading...




3

Remdesivir: early findings on experimental coronavirus drug offer 'quite good news'

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

Continue reading...




3

Covid-19 could mark a deadly turn in Ghana's fight against fake drugs

With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’

When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.

She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.

The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance

Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock

Continue reading...




3

Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.




3

NICE backtracks to approve Janssen's Stelara in ulcerative colitis

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.




3

EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.




3

Pharmafile.com's weekly COVID-19 news round-up

Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his position due to his pushback to the administration focusing on the use of hydroxychloroquine in COVID-19 patients. This came after the National Institutes of Health said coronavirus patients should not take the drug due to potential “toxicities.”




3

Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.




3

Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.




3

Teva’s cancer drug Bendeka protected from generics until 2031, judge rules

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.




3

Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.




3

Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.




3

FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




3

Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.




3

Pharmafile.com's weekly COVID-19 news round-up

Vaccines and treatments for COVID-19 continue to dominate the news, as two studies reveal "positive" data for Gilead's remdesivir in hospitalised coronavirus patients while Lonza and Moderna have entered an agreement to mass produce a vaccine.




3

AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.




3

UK becomes first European country to pass 30,000 deaths from COVID-19

Britain has become the first European nation to pass 30,000 deaths from the coronavirus, putting it only behind the US as the worst hit country in the world in terms of fatalities.




3

NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.




3

FTC clears AbbVie’s $63bn Allergan takeover

US regulator satisfied that antitrust concerns are remediated




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FDA Works - 24846557832

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24870613541

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24871136551

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24937541436

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24938398436

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24963817515

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24963850865

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24964138315

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




3

FDA Works - 24964391365

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.




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Elanco to Buy Bayer's Animal Health Business for $7.6 Billion

Click to view a price quote on ELAN.




3

Clinical tests imminent for Junshi's COVID-19 antibody

A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel…



  • Anti-virals/Biotechnology/China/Coronavirus/Drug Trial/Eli Lilly & Company/Focus On/JS016/Junshi Biosciences/Research/USA

3

Bristol-Myers' CAR-T cell therapy meets with FDA delay

The submission of additional information, upon the request of the US regulator, has delayed the action…



  • Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA

3

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

3

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

3

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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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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Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.




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Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.




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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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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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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.