Search This Blog

Wednesday, September 1, 2021

ABVC BioPharma in New Patent Filings for MDD, ADHD Treatments

  ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced it has filed new PCT (Patent Cooperation Treaty) applications in connection with its medicines that treat major depressive disorder (MDD) and Attention-Deficit Hyperactivity Disorder (ADHD). The two PCT applications describe the treatment methods of oral administrating compositions containing Radix Polygalae (Polygala tenuifolia Willd) extract (PDC-1421). PDC-1421 is the active ingredient for both the company’s MDD and ADHD drugs.

A recently completed Phase II Part II clinical study for ABVC’s MDD medicine was a randomized, double-blind, placebo-controlled, multi-center trial, involving 60 adult patients with confirmed moderate to severe MDD who were treated with PDC-1421 three times a day for six weeks. PDC-1421 met the pre-specified primary endpoint by demonstrating a highly significant 13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score by Intention-To-Treat (ITT) analysis, averaged over the 6-week treatment period (overall treatment effect) from baseline, as compared to 9.2-point reduction of the placebo group. By Per-Protocol (PP) analysis, PDC-1421 showed a dose dependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-point reduction in MADRS total score from baseline and low dose (380 mg) gave 10.4-point reduction as compared to 8.6 in the placebo group. The patients exhibited no severe adverse events.

“We believe that the PCT filings, which provide quick entries to PCT contracting countries, such as China, Japan and European Union, can facilitate the global IP protection of our important MDD and ADHD products,” said Dr. Howard Doong, ABVC BioPharma chief executive officer. “The PCT’s and subsequent national phase applications, when granted, can extend our product’s global market exclusivity to 2040~2041.”


Bellicum, MD Anderson in Additional License Pact for CaspaCIDe® Safety Switch Use

 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, and The University of Texas MD Anderson Cancer Center today announced a global option and license agreement covering certain intellectual property and technology rights regarding Bellicum’s CaspaCIDe® (inducible caspase-9, or iC9) safety switch and related technologies, and the use of rimiducid, an agent used to activate the safety switch. Under this agreement, MD Anderson will have the option to incorporate CaspaCIDe into certain cellular therapy programs.

Bellicum’s CaspaCIDe safety switch may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next-generation higher potency cell therapy constructs.

https://finance.yahoo.com/news/bellicum-md-anderson-announce-additional-113000753.html

BioCryst Say U.S. Government Excercises Option to Buy Flu Treatment

 BioCryst Pharmaceuticals Inc. on Wednesday said the U.S. Department of Health and Human Services has exercised its option to buy more doses of the company's antiviral influenza treatment Rapivab.

In the deal, the government will buy 10,000 additional doses of the drug for the strategic national stockpile for about $7 million, the company said.

After fulfilling the order, BioCryst will have delivered 40,000 doses of the drug under the contract, it said.

https://www.marketscreener.com/quote/stock/BIOCRYST-PHARMACEUTICALS-8534/news/BioCryst-Say-U-S-Government-Excercises-Option-to-Buy-Rapivab-Doses-36297357/

North Korea turns down Sinovac COVID-19 vaccine doses

 North Korea has rejected roughly three million COVID-19 vaccine doses developed by China's Sinovac Biotech, saying the shots should be sent to harder-hit countries, the Wall Street Journal reported on Wednesday, citing UNICEF.

The agency, which helps deliver COVID-19 shots on behalf of the COVAX scheme, told WSJ that North Korea's public health ministry declined the shipment, citing the limited global supply for vaccines and continuing virus surges elsewhere.

North Korea had in July rejected shipments of AstraZeneca's COVID-19 vaccine due to concerns over side effects, according to a South Korean think-tank.

The reclusive country has not reported any COVID-19 cases and has imposed strict anti-virus measures, including border closures and domestic travel curbs.

UNICEF did not immediately respond to Reuters' request for comment.

"We continue to work with DPRK authorities to help respond to the COVID-19 pandemic," a spokesperson for the Global Alliance for Vaccines and Immunization alliance, one of the organizations that co-leads COVAX, said in an emailed statement.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-North-Korea-turns-down-Sinovac-COVID-19-vaccine-doses-WSJ-36297501/

Pfizer starts dosing patients in oral COVID-19 drug trial

 Pfizer Inc said on Wednesday it had started dosing in a mid-to-late-stage trial of its oral antiviral therapy for COVID-19 in non-hospitalized, symptomatic adult patients.

The company and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop the first antiviral pill to be taken on early signs of the illness.

Pfizer's mid-to-late-stage trial in 1,140 participants would study the therapy, PF-07321332, in combination with a low dose of ritonavir, which has been used with other antivirals too, the company said. (https://bit.ly/3kJWzg9)

PF-07321332 is designed to block the activity of a key enzyme that is needed for the coronavirus to replicate.

To date, Gilead Sciences Inc's remdesivir, administered intravenously, is the only approved antiviral treatment for COVID-19 in the United States.

Merck and partner Ridgeback Biotherapeutics' molnupiravir is already being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.

The companies said on Wednesday they had started a late-stage trial of molnupiravir for the prevention of COVID-19 infection.

Pfizer said in July if the PF-07321332 trial was successful, it would file for a potential emergency use authorization in the fourth quarter.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Pfizer-starts-dosing-patients-in-oral-COVID-19-drug-trial-36297881/

Moderna says Takeda plans to recall three lots of suspended COVID-19 vaccine

 Moderna Inc said on Wednesday its Japanese distribution partner, Takeda Pharmaceutical Co Ltd , planned to initiate the recall of three lots of its COVID-19 vaccine that were suspended due to contamination.

Japan's health ministry said particles of stainless steel were found in suspended Moderna COVID-19 vaccines, but it did not expect they would pose an additional health risk.

https://www.marketscreener.com/quote/stock/TAKEDA-PHARMACEUTICAL-COM-6491073/news/Takeda-Pharmaceutical-Moderna-says-Takeda-plans-to-recall-three-lots-of-suspended-COVID-19-vaccine-36300562/

Factories hit by pandemic-related supply disruptions

 

Global factory activity lost momentum in August as the ongoing coronavirus pandemic-disrupted supply chains, raising concerns faltering manufacturing would add to economic woes caused by slumping consumption, surveys showed on Wednesday.

Many firms reported logistical troubles, product shortages and a labour crunch which have made it a sellers' market of the goods factories need, driving up prices.

While factory activity remained strong in the euro zone, IHS Markit's final manufacturing Purchasing Managers' Index (PMI) fell to 61.4 in August from July's 62.8, below an initial 61.5 "flash" estimate.

"Despite the strong PMI figures, we think that lingering supply-side issues and related producer price pressures might take longer to resolve than previously expected, increasing the downside risk to our forecast," said Mateusz Urban at Oxford Economics.

In Britain, where factories also faced disruptions, manufacturing output grew in August at the weakest rate for six months. The United States likely suffered a similar slowdown, data is expected to show later on Wednesday. [GB/PMIM]

Canada's economy unexpectedly shrank last quarter and in July, official data showed on Tuesday - hurt by decreases in manufacturing, construction and retail trade - and Australia reported slower growth in the second quarter on Wednesday.

CHINA BRAKES

Meanwhile, Southeast Asia - a low-cost manufacturing hub for many global companies - was hit particularly hard with factory activity shrinking in Vietnam, Indonesia and Malaysia because of virus outbreaks and output suspensions.

And in a worrying sign for the global economy, China's factory activity slipped into contraction in August for the first time in nearly 1-1/2 years as COVID-19 curbs, supply bottlenecks and high raw material prices weighed on output.

China's Caixin/Markit Manufacturing PMI fell to 49.2 in August, from 50.3 in July, breaching the 50-mark separating growth from contraction.

The result was well below market expectations, underscoring the fragile nature of China's recovery that had helped the global economy emerge from pandemic-induced doldrums.

The private survey followed an official PMI on Tuesday, which showed the index falling in August but staying above the 50 mark.

"The elephant in the room for the long North Asia, short ASEAN view is China. This morning, the Caixin Manufacturing PMI followed yesterday's official number South, falling under 50," said Jeffrey Halley at OANDA.

"That rounds out a grim week for China's PMIs as COVID-19 lockdowns and the same supply chain challenges the rest of the world is experiencing erode economic performance."

Export power-houses Japan, South Korea and Taiwan also saw manufacturing activity expand at a slower pace in August, a sign chip shortages and factory shutdowns in the region could delay a sustained recovery from the pandemic-induced slump.

The surveys highlight the pandemic's broadening damage in Southeast Asia, where soaring infections and subsequent lockdown measures have hurt both the service and manufacturing sectors.

Delta variant outbreaks in the region have caused supply chain headaches for the world's largest manufacturers, many of which rely on auto parts and semiconductors made in low-cost bases such as Thailand, Vietnam and Malaysia.

"If the strict lockdown measures continue, Southeast Asia may find it hard to remain a global production hub," said Makoto Saito, an economist at NLI Research Institute.

Japan's PMI eased and new export orders posted their first contraction since January. South Korea's index fell to 51.2.

In Vietnam and Malaysia, activity was hurt by lockdown measures and rising infections that forced some factories to suspend operations. Vietnam saw factory activity shrink while Malaysia's PMI stood at 43.4 in August.

Once seen as a driver of global growth, Asia's emerging economies are lagging advanced economies in recovering from the pandemic's pain as delays in vaccine rollouts and a spike in Delta variant cases hurt consumption and factory production.

Growth in India's factory sector activity slowed as persistent pandemic-related weakness weighed on demand and output, forcing firms to cut jobs again following a brief recovery in July.

https://www.marketscreener.com/news/latest/Factories-hit-by-pandemic-related-supply-disruptions--36293905/