Novartis prostate cancer drug receives U.S. FDA breakthrough designation

 Swiss drugmaker Novartis AG has received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the company said on Wednesday.

Men with a deadly form of prostate cancer that has spread and who were not helped by other treatments on average survived four months longer after getting Novartis' Lu-PSMA-617 - a tumour-targeting radiation therapy - than those who received standard care, data from a clinical trial released earlier in June showed.

The therapy attaches a radioactive isotope, lutetium-177, with a half-life of less than seven days, to a small molecule drug, PSMA-617, that binds to an antigen expressed in large amounts by prostate cancer cells. It aims to kill cancer cells in a targeted way while limiting damage to surrounding, healthy cells.

The FDA breakthrough designation is used to help expedite development and review of therapies that demonstrate the potential to be a substantial improvement over available treatments.

Novartis, which acquired the therapy with its $2.1 billion purchase of Endocyte three years ago, has a growing portfolio of radioligand medicines that includes already approved cancer therapy Lutathera.

Prostate cancer can often be treated via surgery, radiation therapy or through hormone therapy that stops production of tumour-driving testosterone.

Metastatic castration-resistant prostate cancer, however, has failed to respond to such hormone treatment, making it difficult to treat - and a potentially lucrative market. Novartis has forecast eventual Lu-PSMA-617 annual sales topping $1 billion.

https://finance.yahoo.com/news/1-novartis-prostate-cancer-drug-160848053.html

China ramps up vaccinations, but uneven rollout leaves borders closed

 China has tripled its daily COVID-19 vaccine rollout in June, inoculating 44% of its population with at least one dose, but its health experts warn against a quick border reopening, citing an uneven rollout and the low rate of full vaccinations.

China rolled out 17.3 million doses per day in June on average, up sharply from 4.8 million in April, as it expanded the list of approved vaccines to seven by adding three more locally-developed shots, and continued to boost production.

But the rollout has been uneven.

By the first week of June, major cities of Beijing and Shanghai fully inoculated nearly 70% and 50% of their residents respectively, but the rate in Guangdong and Shandong provinces remained below 20%.

"(China) is such a big country... Once any of its places open up, it will have a big impact on places that haven't reached high vaccination levels," Feng Zijian, a researcher at Chinese Center for Disease Control and Prevention, said earlier this month.

Feng said that China is yet to reach a consensus on what vaccination rate will safely allow adjusting virus control measures, including loosening requirement of quarantine or virus testing for inbound travellers.

China will also wait and see how Japan handles its virus outbreak and the Tokyo Olympics next month before deciding how quickly Beijing needs to loosen its border controls, a person familiar with the situation said.

China is also stepping up vaccinations in preparation to host the Winter Olympics early next year.

Several counties and districts of Zhangjiakou city in northern China, which will host some of the Games, are urging residents to get vaccinated, saying it is a "necessary contribution" that they should make for the international event.

As part of the city's vaccination campaign, more than 1,800 unvaccinated visitors were dissuaded from entering a park in the Xuanhua district earlier this month and guided to nearby inoculation sites, according to a social media post by the district-level authorities.

"There isn't much time and the task is heavy," Wu Weidong, head of the city-level committee of the Communist Party, said in a statement earlier this month.

It said the city is still short of its vaccination target without detailing its target or inoculation rate.

ZERO TOLERANCE

China has kept local transmission in check by conducting large-scale COVID tests and seal up neighbourhoods and streets when new cases emerged. It refuses to abandon this "zero-tolerance" playbook, even though local outbreaks are tiny compared with those in other countries.

Zhang Wenhong, director of an expert team on COVID-19 treatment in Shanghai city, said at a recent conference it would be too early to drop the policy or fully open up until the full vaccination rate hits at least 70%.

For China, the flip side of low local transmission has been difficulty in gauging clearly how effectively China's vaccination campaign will help contain the spread of the virus.

Some countries such as Britain and Chile are battling a surge in new cases even as they have among the highest vaccination rates in the world, a cautionary tale for China.

Chile, which used a vaccine developed by China's Sinovac as its major vaccination tool, said on Monday it would extend a COVID-19 emergency through September, as cases have soured to some of their highest levels since the pandemic began.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-nbsp-China-ramps-up-vaccinations-but-uneven-rollout-leaves-borders-closed-35617261/

Feds Buy Additional 200 Million Doses of Moderna’s COVID-19 Vaccine

 Total of 500 million doses ordered by the U.S government to date, including 110 million doses for delivery in the fourth quarter of 2021 and 90 million doses for delivery in the first quarter of 2022

Additional doses will ensure the U.S. government continues to receive the Moderna COVID-19 Vaccine through the first quarter of 2022

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.

This purchase brings the U.S. government’s confirmed order commitment to 500 million doses including 110 million doses expected to be delivered in the fourth quarter of 2021 and 90 million expected to be delivered in the first quarter of 2022. As of June 14, Moderna has supplied 217 million released doses of the vaccine to the U.S. government.

“We appreciate the collaboration with the U.S government for these additional doses of the Moderna COVID-19 vaccine, which could be used for primary vaccination, including of children, or possibly as a booster if that becomes necessary to continue to defeat the pandemic,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain focused on being proactive as the virus evolves by leveraging the flexibility of our mRNA platform to stay ahead of emerging variants.”

https://www.streetinsider.com/Business+Wire/U.S.+Government+Purchases+Additional+200+Million+Doses+of+Moderna%E2%80%99s+COVID-19+Vaccine/18565930.html

Fed holds rates at near zero, projects two possible rate hikes by end of 2023

 The Federal Reserve on Wednesday held interest rates at near-zero but optimism over the progression of the U.S. economic recovery spurred more Fed officials to pencil in rate hikes by the end of 2023.

The Fed also reiterated for now its commitment to its asset purchase program, which is absorbing about $120 billion a month in assets.

“Progress on vaccinations will likely continue to reduce the effects of the public health crisis on the economy, but risks to the economic outlook remain,” the Federal Open Market Committee said in a statement.

A fresh round of its quarterly economic projections reflected the central bank’s optimism over the economic outlook, with 13 of the FOMC’s 18 members projecting at least one rate hike by the end of 2023.

The Fed's June 2021 Summary of Economic Projections show the median member of the central bank's policy-setting committee seeing the case for two rate hikes by the end of 2023. Source: Federal Reserve

The median member of the FOMC in the so-called “dot plot,” which maps out each member’s expectations for rates over coming years, now expects two rate hikes by the end of 2023.

For comparison, the Fed’s dot plots in March of this year showed the median member expecting no rate hikes through that time horizon.

The upward revision suggests that the Fed sees a faster-than-expected recovery. The economic projections raised expectations for real GDP growth in 2021 to 7.0%, a notch up from March projections for 6.5%.

The Fed however, maintained its March expectation for the headline unemployment rate to end 2021 at 4.5%.

Tapering?

The Fed statement reiterated that for now the central bank will continue to purchase at least $120 billion a month in agency mortgage-backed securities and U.S. Treasuries as part of its quantitative easing program.

The decision to hold interest rates at near-zero was unanimous among the voting members of the FOMC.

But chatter is building within the central bank over kicking off discussions about when to begin slowing the pace of those purchases. Those eager to begin the “taper talks” have also expressed concern over the risk of rising inflation.

The FOMC’s Summary of Economic Projections show the median member of the committee viewing inflation rising at a faster clip than its last round of forecasts in March, expecting core personal consumption expenditures (the Fed’s preferred measure of inflation) clocking in at 3.0% in 2021 (compared to 2.2% in its March forecast).

The Fed’s inflation target is 2%.

Other changes

The Fed also made a technical change by saying it would raise the interest it pays on reserves and excess reserves, from 0.10% to 0.15%.

The tweak does not change the Fed’s interest rate target, which remains unchanged at a range between 0% and 0.25%. But banks, swelling with deposits amid the Fed’s money printing, have been lending overnight funds at rates closer to the bottom of that range.

Raising the interest it pays on reserves by 5 basis points should in theory move the effective interest rate closer to the middle of its range.

The Fed also announced it would extend its temporary U.S. dollar liquidity swap lines with nine central banks through December 31, 2021. The swap lines were originally set to expire in September 2021.

https://finance.yahoo.com/news/fed-fomc-monetary-policy-decision-june-2021-143205185.html

United Therapeutics NDA for Tyvaso DPI to Get Priority Review

 United Therapeutics Corp. said the U.S. Food and Drug Administration has accepted for priority review the New Drug Application for Tyvaso DPI inhaled treprostinil for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The company said it expects the agency's review to be complete in October. The FDA also indicated that it hasn't identified any potential review issues at this time.

Tyvaso DPI is a next-generation dry powder formulation of Tyvaso. If approved, Tyvaso DPI is expected to provide a more convenient method of administration compared with traditional nebulized Tyvaso therapy.

The NDA includes data from a study that demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso treprostinil inhalation solution. A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso inhalation solution.

In its communications with United Therapeutics, the FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind Corp. FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.

https://www.marketscreener.com/quote/stock/UNITED-THERAPEUTICS-CORPO-11262/news/United-Therapeutics-NDA-for-Tyvaso-DPI-to-Get-Priority-Review-35619657/

Atea Pharma Hits Development Milestone for Covid-19 Treatment

 Atea Pharmaceuticals Inc. said it has achieved a milestone associated with the development of AT-527, and expects to receive a related payment under its license agreement with Roche of $50 million.

Under the license agreement, Roche and Atea are jointly developing AT-527 for the treatment of Covid-19.

AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide pro-drug platform, and it is in Phase 3 development for the treatment of Covid-19, Atea said.

Atea retains rights to commercialize AT-527 in the U.S., and Roche has the exclusive right to commercialize AT-527 outside the U.S.

https://www.marketscreener.com/quote/stock/ATEA-PHARMACEUTICALS-INC-114338425/news/Atea-Pharma-Hits-Development-Milestone-for-Covid-19-Treatment-35620502/

Prothena, Lilly ride coattails of Biogen FDA win

 The U.S. Food and Drug Administration (FDA) granted accelerated approval to Biogen's (NASDAQ:BIIB) Alzheimer's disease drug Aduhelm (aducanumab) on Monday. This news caused shares of the biotech to soar 44.9% this week as of the market close on Thursday.

Biogen wasn't the only beneficiary, though. The stocks of other companies developing experimental Alzheimer's disease therapies also jumped on news of the FDA approval of Aduhelm.

Shares of Eli Lilly (NYSE:LLY), which is evaluating two candidates in late-stage clinical studies targeting the neurodegenerative disorder, rose 15.6%. Shares of Prothena (NASDAQ:PRTA) skyrocketed 55.4% after Oppenheimer increased its price target for the biotech stock to $54 on increased optimism about the prospects for the company's two preclinical Alzheimer's disease programs. 

It's easy to understand why Biogen's shares took off so much. The company should have a surefire blockbuster on the way with Aduhelm. The drug is the first therapy approved by the FDA for treating Alzheimer's disease in nearly two decades. 

Biogen announced that Aduhelm will have a list price that translates to $56,000 per year. Around 6 million Americans are diagnosed with Alzheimer's disease. If the drug is prescribed for just 100,000 of those patients, Biogen stands to rake in close to $5.6 billion annually in sales at the list price. 

The positive FDA decision on Aduhelm could also bode well for Lilly's prospects for donanemab. Lilly reported results from a phase 2 study of the drug in March that showed that it appeared to slow cognitive decline in Alzheimer's disease patients. 

Lilly's other late-stage Alzheimer's drug, solanezumab, wasn't successful in an earlier late-stage clinical study. However, the company hopes for better results in another ongoing phase 3 study of the experimental therapy with asymptomatic patients with Alzheimer's disease. 

Why the excitement about Prothena, which is well behind both Biogen and Lilly? Oppenheimer thinks that the biotech's PRX012 could be more effective than Aduhelm in treating Alzheimer's disease. It also believes that the FDA's approval of Aduhelm established a precedent that should make it easier for other antibodies that target beta-amyloid (as Aduhelm does) to make it to market in the future. 

The FDA's approval for Aduhelm was highly controversial. The agency's own advisory committee overwhelmingly recommended against approval of the drug. It remains to be seen how this controversy could impact physicians' prescribing choices and payer reimbursement.

Investors will want to watch to see if Lilly opts to seek accelerated approval for donanemab in light of the approval for Aduhelm. The big drugmaker previously stated that it wouldn't do so. As for Prothena, the company hopes to file in the first quarter of 2022 for FDA approval to advance PRX012 into early-stage clinical testing.

https://www.fool.com/investing/2021/06/10/why-biogen-lilly-and-prothena-stocks-soared-this-w/