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Friday, December 11, 2020

Merck, Pfizer Get Positive CHMP Opinion on Bavencio for Bladder Cancer

 Merck KGaA said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has given a positive opinion recommending approval of bladder-cancer treatment Bavencio, which it developed in a partnership with Pfizer Inc.

The German pharmaceuticals-and-chemicals company said that the European Commission will review the agency's opinion and that a decision is expected in early 2021.

The drug was given a recommendation for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma, or bladder cancer, Merck said. Bavencio is an immunotherapy which was proven to prolong overall survival in patients suffering from that type of cancer during a phase 3 trial.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Merck-Pfizer-Get-Positive-CHMP-Opinion-on-Bavencio-for-Bladder-Cancer-31993395/

EU drugs regulator endorses changes to remdesivir marketing for COVID-19 use

 

Europe's drugs regulator on Friday recommended changing some terms of the conditional approval given to antiviral drug remdesivir as a COVID-19 treatment, to make clear the conditions under which it can be used.

Doubts over remdesivir's effectiveness were raised after the World Health Organization (WHO) last month said the drug should not be used for COVID-19 patients, regardless of how ill they are, just months after Europe and the United States approved the treatment.

The new terms of the conditional marketing authorisation in Europe add that a patient could need "low- or high-flow oxygen or other non-invasive ventilation at start of treatment," according to the European Medicines Agency. (https://bit.ly/2W4BQb9)

The drug, made by U.S. drugmaker Gilead Sciences Inc, is already indicated for use in Europe in patients aged 12 years and older with body weight at least 40 kg, who are also suffering from pneumonia and require oxygen support.

The European Union in October agreed to pay more than 1 billion euros ($1.2 billion) to Gilead for a six-month supply.

Research by British scientists showed remdesivir's benefits, but a WHO-lead trial found there was no evidence the drug improves survival or reduces the need for ventilation, a claim Gilead has questioned.

The top U.S. infectious disease medical association had backed remdesivir for COVID-19 treatment days after the WHO warning.

A EU conditional marketing authorisation allows a treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side-effects are available.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-EU-drugs-regulator-endorses-changes-to-remdesivir-marketing-for-COVID-19-use-31993080/

FDA 'working rapidly' on Pfizer COVID-19 vaccine decision

 

The U.S. Food and Drug Administration (FDA) said on Friday it was working rapidly to issue an emergency use authorization for Pfizer Inc's COVID-19 vaccine, setting the stage for the first Americans to be immunized as soon as Monday or Tuesday.

The FDA's decision making follows one of the last steps of its regulatory process: a panel of outside advisers on Thursday evening endorsed emergency use of the vaccine to help stem a pandemic that has killed more than 285,000 U.S. residents.

U.S. Department of Health and Human Services Secretary Alex Azar, which oversees the FDA, told ABC News that regulatory authorization should come within days and the federal government would work with the company to get the vaccine shipped out.

Pfizer has asked that the two-dose vaccine, developed with German partner BioNTech, be approved for use in people aged 16 to 85.

The companies last month said that a two-dose regimen of the vaccine was 95% effective in preventing illness from COVID-19, and detailed data released in the FDA's documents showed the vaccine began showing some protection even before volunteers received a second dose.

The vaccine is already approved in Britain, and people there began receiving the shots on Tuesday. Bahrain and Canada have also authorized the vaccine, and Canada expects to start inoculations next week.

The FDA has notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed so that they can execute their plans for timely vaccine distribution, it said in a statement. (https://bit.ly/2W47i9l)

Healthcare workers, first responders and nursing home residents are expected to receive the first doses, but a wider rollout faces significant logistical challenges.

Another 2,902 U.S. deaths were reported on Thursday, a day after a record 3,253 people died, a pace projected to continue for the next two to three months until the vaccine can be widely distributed.

For months, U.S. President Donald Trump had pressured the FDA in tweets and press conferences to move more quickly, accusing staff and Pfizer of dragging their feet.

Shortly after the FDA's statement, the outgoing president criticized the agency for what he said was its slow handling of the vaccines and criticized FDA Commissioner Steven Hahn.

Trump said his "pushing" the agency had speed up new vaccine approval, but that the FDA was "still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!"

https://www.marketscreener.com/news/latest/U-S-FDA-working-rapidly-on-Pfizer-COVID-19-vaccine-decision--31992627/

AstraZeneca hitches ride with Russia's Sputnik in vaccine race

 

AstraZeneca will start clinical trials to test a combination of its experimental COVID-19 vaccine with Russia's Sputnik V shot aimed at boosting the efficacy of the British drugmaker's vaccine, Russia's sovereign wealth fund said on Friday.

Trials will start by the end of the year and Russia wants to jointly produce the new vaccine if it is proven to be effective, said the RDIF wealth fund, which has funded Sputnik V, named after the Soviet-era satellite that triggered the space race.

AstraZeneca, in a statement on Friday, said it was considering how it could assess combinations of different vaccines, and would soon begin exploring with Russia's Gamaleya Institute, which developed Sputnik V, whether two common cold virus-based vaccines could be successfully combined.

It did not give further details. However, its Russian arm said it would start to enrol adults aged 18 years and older to the trial.

The co-operation between one of Britain's most valuable listed companies and the state-backed Russian science research institute highlights the pressure to develop an effective shot to fight the pandemic that has killed over 1.5 million people.

The move is likely to be seen in Moscow as a long-awaited vote of confidence by a Western manufacturer in Sputnik V.

Its Russian developers say clinical trials, still underway, have shown it has an efficacy rate of over 90%, higher than AstraZeneca's own vaccine and similar to U.S. rivals Pfizer and Moderna.

Some Western scientists have raised concerns about the speed at which Russia has worked, giving the regulatory go-ahead for its vaccines and launching large-scale vaccinations with Sputnik V before full trials to test its safety and efficacy have been completed. Russia has rejected such criticism as unfounded.

The prospective tie-up comes as AstraZeneca, once seen as a frontrunner in the vaccine race, prepares for further tests to confirm whether its shot could be 90% effective, potentially slowing its rollout.

The average efficacy rate was 70.4% in interim late-stage data.

TWITTER DIPLOMACY

The partnership came about after the developers of Sputnik V suggested on Twitter last month that AstraZeneca try the combination after the British drugmaker released interim results from its late-stage trial.

The British drugmaker accepted the proposal, the RFID said on Friday.

"The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine's efficacy is an important step towards uniting efforts in the fight against the pandemic," said RDIF head Kirill Dmitriev in a statement.

"We hope that other vaccine producers will follow our example."

Earlier this week, Kate Bingham, chair of Britain's vaccine taskforce, said the country would start trials next year using combinations of different kinds of vaccine for the initial and booster vaccinations, in the hope that a "mix-and-match" approach might maximise the immune response.

Both projects are using harmless adenoviruses as vehicles to bring genetic instructions into the body to prompt cells to produce vaccine proteins, an approach that has previously been used in an Ebola vaccine.

One common challenge of such a method is that the immune system could attack the adenovirus vehicle, known as the viral vector, and in particular neutralise the staggered booster shot that is now an important feature of the leading COVID-19 vaccine candidates.

Using different viral vectors for the primer and booster shot is one approach that researchers, including at the Gamaleya Institute, have pursued. Combining vaccines from different developers could also be a way around that.

AstraZeneca and partner Oxford University have used a harmless adenovirus only found in monkeys to rule out that people receiving the shot had previous exposure and therefore an immune defence against it.

AstraZeneca did not mention immunity against the viral vector as an issue in its statement on Friday.

Still, Russian officials have not always been complimentary about the British vaccine.

When the company paused a clinical trial in September due to the unexplained illness of a volunteer, Kremlin spokesman Dmitry Peskov told reporters that Sputnik V was a more reliable vaccine because it was based on an adenovirus found in humans, whereas the British candidate was "a monkey vaccine."

The partnership may draw scrutiny after Britain said in July hackers backed by the Russian state were trying to steal COVID-19 vaccine and treatment research from academic and pharmaceutical institutions around the world. The Kremlin rejected the Western allegations.

The news came as Sanofi and GlaxoSmithKline said clinical trials of their COVID-19 vaccine showed an insufficient immune response in older people.

https://www.marketscreener.com/quote/stock/V-TECHNOLOGY-CO-LTD-6814827/news/AstraZeneca-hitches-ride-with-Russia-s-Sputnik-in-vaccine-race-31991042/

Roche teams up with Diabeloop to advance insulin pump therapy

 

  • Roche (OTCQX:RHHBY) is partnering with the French MedTech company Diabeloop to advance the management of insulin pump therapy, for people with diabetes and to improve therapy outcomes.
  • The partnership marks Roche's first step in the field of automated insulin delivery (AID) representing a milestone in Roche's strategy of integrated Personalised Diabetes Management (iPDM).
  • "The technology of Diabeloop, based on a self-learning algorithm, is unique. We are convinced that the potential of the hybrid closed-loop systems will contribute to a more efficient and personalised approach of diabetes management," said Marcel Gmuender, Global Head of Roche Diabetes Care.
  • https://seekingalpha.com/news/3643592-roche-teams-up-diabeloop-to-advance-insulin-pump-therapy

COVID-19 antibody therapy developer AbCellera Bio prices IPO above range at $20

 

EMA backs Xeris Ogluo as treatment in severe hypoglycemia