FDA OKs Incyte/Morphosys’ tafasitamab for treatment-resistant lymphoma

Morphosys AG (NASDAQ:MOR) and collaboration partner/licensee Incyte (NASDAQ:INCY) announce the FDA nod for Monjuvi (tafasitamab-cxix), combined with lenalidomide, for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Under the terms of their January 2020 agreement, the companies will co-commercialize the the humanized Fc-modified cytolytic anti-CD19 monoclonal antibody in the U.S. while INCY will exclusively commercialize ex-U.S.

U.S. commercial launch will commence shortly.

https://seekingalpha.com/news/3598655-fda-oks-incyte-morphosys-tafasitamab-for-treatment-resistant-lymphoma

FDA OKs new use of GW Pharma’s Epidiolex

GW Pharmaceuticals (NASDAQ:GWPH) unit Greenwich Biosciences announces the FDA nod for the use of Epidiolex (cannabidiol) oral solution to treat seizures associated with tuberous sclerosis complex (TSC) in patients at least one year old.

TSC is an inherited disorder characterized by the growth of benign tumors in many parts of the body. Sufferers may experience seizures when they form in the brain.

The agency reviewed the application under Priority Review status.

Epidiolex was first approved in the U.S. in June 2018 for the treatment of seizures associated with two rare and severe types of childhood epilepsy called Dravet syndrome and Lennox-Gastaut syndrome.

https://seekingalpha.com/news/3598672-fda-oks-new-use-of-gw-pharmas-epidiolex

FDA OKs first semi-quantitative blood tests for COVID-19 antibodies

The FDA approves two blood tests developed at Siemens (OTCPK:SIEGY), the ADVIA Centaur COV2G and Attelica COV2G, that estimate the quantity of a patient’s antibodies against the SARS-CoV-2 virus. The semi-quantitative assays are the first such tests approved in the U.S.

Being able to estimate the quantity of antibodies may be useful in determining the degree of immunity against subsequent infection.

All the serology tests approved to date are qualitative, meaning that they detect the presence of antibodies (a “yes/no” result) but not the specific quantities.

https://seekingalpha.com/news/3598675-fda-oks-first-semi-quantitative-blood-tests-for-covidminus-19-antibodies

Trump administration can cut drug subsidies to hospitals: U.S. court

A divided U.S. appeals court on Friday ruled the Trump administration had the authority to reduce subsidies Medicare pays certain hospitals to obtain discounted pharmaceutical medications.

The U.S. Court of Appeals for the District of Columbia Circuit by a 2-1 vote overturned a judge’s decision that the administration lacked authority to cut such payments by $1.6 billion in 2018.

The cuts reduced subsidies for purchases by nonprofit hospitals of outpatient drugs bought through the 340B Drug Pricing Program, which allows them to buy medications at steep discounts and seek reimbursement.

A 2017 rule by the U.S. Department of Health and Human Services sought to address a gap between the discounted drug prices and the reimbursement rate that gave hospitals a substantial profit margin.

The American Hospital Association and hospitals sued, arguing HHS’ 28.5% rate cut rested on an impermissible interpretation of the statute governing Medicare, the government healthcare program for people aged 65 and older.

U.S. Circuit Judge Sri Srinivasan, writing for the majority, said “HHS’s decision to lower drug reimbursement rates for 340B hospitals rests on a reasonable interpretation of the Medicare statute.”

U.S. Circuit Judge Cornelia Pillard dissented, saying the statute did not allow HHS to “take a major bite” out of funding for “financially strapped, public and nonprofit safety-net hospitals serving vulnerable populations.”

HHS Secretary Alex Azar called the ruling a “major victory for President Trump’s agenda of lower drug prices and better healthcare for all Americans.”

The American Hospital Association called on the administration to reverse the “harmful policy.”

Trump’s administration has argued the payment system in place before the rate cuts led to unnecessarily high Medicare spending on prescription drugs.

It again cut the reimbursement rate for 2019, though U.S. District Judge Rudolph Contreras last year held that the change, like the 2018 ones, was unlawful.

https://www.reuters.com/article/us-usa-court-hospitals-lawsuit/trump-administration-can-cut-drug-subsidies-to-hospitals-u-s-court-idUSKCN24W2RJ

Russia preparing mass vaccination against coronavirus for October

Russia’s health minister is preparing a mass vaccination campaign against the novel coronavirus for October, local news agencies reported on Saturday, after a vaccine completed clinical trials.

Health Minister Mikhail Murashko said the Gamaleya Institute, a state research facility in Moscow, had completed clinical trials of the vaccine and paperwork is being prepared to register it, Interfax news agency reported.

He said doctors and teachers would be the first to be vaccinated.

“We plan wider vaccinations for October,” Murashko was quoted as saying.

A source told Reuters this week that Russia’s first potential COVID-19 vaccine would secure local regulatory approval in August and be administered to health workers soon thereafter.

The Gamaleya Institute has been working on an adenovirus-based vaccine.

Yet the speed at which Russia is moving to roll it out has prompted some Western media to question whether Moscow is putting national prestige before science and safety.

The head of the Russian Direct Investment Fund, Kirill Dmitriev, has likened what he said was Russia’s success in developing a vaccine to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite.

On Saturday, Russia reported 95 additional deaths from the novel coronavirus, taking its total to 14,058.

Officials reported 5,462 new cases, raising the total to 845,443.

More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic.

At least four are in final Phase III human trials, according to World Health Organization (WHO) data, including three developed in China and another in Britain.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-preparing-mass-vaccination-against-coronavirus-for-october-idUSKBN24X3KO

Congressional Democrats, White House set for Saturday talks on coronavirus bill

The top Democrats in Congress were to meet Saturday with two top Trump aides to try to reach a deal to pump more money into the U.S. economy to ease the coronavirus’ heavy toll, after an essential lifeline for millions of unemployed Americans expired.

Congress for the past several months has been unable to reach an accord for a next round of coronavirus relief, in a pandemic that has killed more than 150,000 Americans and brought on the sharpest economic collapse since the Great Depression.

U.S. House of Representatives Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer were to meet with Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows beginning at about 9 a.m. EDT (1300 GMT) at the Capitol, according to an aide familiar with the planning.

Congress has so far agreed on about $3 trillion in coronavirus relief.

Pelosi on Friday said she rejected an offer by Republican President Donald Trump’s administration to continue the $600 payments for another week, saying such a move would only make sense “if you are on a path” toward a deal.

“We’re not,” Pelosi told a news conference.

White House officials took their own hard line, accusing Democrats of refusing Trump’s proposals to extend the jobless benefit and a moratorium on home evictions that expired last week.

“What we’re seeing is politics as usual from Democrats on Capitol Hill,” Meadows – a former Republican House member – told reporters.

The House in May passed a $3 trillion deal that addressed a wide range of coronavirus responses, including more money for testing, for elections and support to financially strapped state and local governments.

Senate Majority Leader Mitch McConnell on Monday unveiled his own $1 trillion package, which met immediate resistance both from Democrats, who called it too small, and from members of his own party, who said it was too costly.

Trump, scrambling to prop up a struggling U.S. economy as he runs for re-election in November, has been pushing for another bill.

In a meeting on Thursday night between top White House officials and congressional Democratic leaders, negotiations focused on an extension of the $600 per week in federal unemployment benefits, which Americans who lost jobs because of the health crisis have been receiving in addition to state jobless payments.

According to a person familiar with the closed-door negotiations, the White House proposed continuing the $600 weekly unemployment payment for one week, which Pelosi and Schumer rejected. The White House then proposed reducing the $600 weekly payment to $400 for the next four months. While that was a move toward Democrats’ demands, the source said they rejected it as insufficient.

The source, who asked not to be identified, said the White House also hinted it could embrace a deal without the legal protections from lawsuits for companies and schools that McConnell has said must be included.

On Thursday, Senate Republicans tried, without success, to pass a bill reducing the jobless benefit to $200 per week.

https://www.reuters.com/article/us-health-coronavirus-usa-congress/congressional-democrats-white-house-set-for-saturday-talks-on-coronavirus-bill-idUSKBN24X3OT

China to add 56 drugs to price-slashing bulk-buy program

China has added 56 medicines, including some global blockbuster drugs, to its state bidding program aimed at procuring key treatments at big discounts in return for offering large-volume state contracts, a state agency said.

The procurement authorities released late on Wednesday the list of drugs open to the upcoming round of bidding.

It includes some products that contributed more than $1 billion each to foreign drugmakers’ sales in 2019 but face challenges from generic versions offered by local drugmakers.

They include AstraZeneca Plc’s heart disease treatment Brilinta, blood-thinning blockbuster Eliquis, jointly developed by Pfizer Inc and Bristol Myers Squibb Co, and Novartis AG’s diabetes drug Galvus.

Beijing has pledged to lower consumer costs of off-patent drugs by pushing forward a national scheme where drugmakers have to go through a bidding process and chop prices low enough to elbow out competitors to be eligible to sell their products at public hospitals in bulk.

The scheme helped China notch up more than 50% of price cuts on average from drugmakers at home and abroad in its previous bidding held in January.

While competition for older brands intensify, Novartis said in an earning call last week that new drug launches are expected to be a main driver of its growth in China.

“We will continue to support the Chinese government’s policies by actively introducing innovative medicines and therefore improving accessibility to benefit more patients in need,” a Novartis representative said in an email.

AstraZeneca and BMS didn’t respond to a request for comment, while Pfizer asked to get in touch with partner BMS for any queries regarding the inclusion of their drug.

For most products on the list, if only one company wins the bid to supply a certain drug, the winner can bag up to half of the total procurement volume in the first year, according to the plan. If a product has at least four bid winners, 80% of the volume can be shared.

Information about drug companies’ applications to participate in the upcoming bidding will be released on Aug. 20 in Shanghai, according to the plan.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/China-to-add-56-drugs-to-price-slashing-bulk-buy-programme-31027765/