Zoetis donates animal COVID-19 vaccine candidate to about 70 U.S. zoos

 Animal health company Zoetis Inc said on Friday it had donated over 11,000 doses of its experimental COVID-19 vaccine to nearly 70 zoos across the United States.

The vaccine has been authorized for experimental use on a case-by-case basis by the United States Department of Agriculture (USDA) and the respective state veterinarians, the company said.

Zoetis, which has provided the vaccine to zoos across 27 U.S. states, supplied it to the San Diego Zoo earlier this year for use in the zoo's great apes following an outbreak that infected several members of a troop of gorillas.

Animals including Asiatic lions in India and a tiger at the Bronx Zoo in New York City have tested positive for COVID-19, but the U.S. Centers for Disease Control and Prevention has said https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/animals.html it does not yet know if all animals can get infected.

Zoetis said the Oakland Zoo in Northern California received their first shipment of vaccines on June 29 and tigers, black and grizzly bears, mountain lions and ferrets were the first to receive the first of two doses.

In addition to zoos, Zoetis' vaccine will be used in over 100 mammalian species in more than a dozen conservatories, sanctuaries, academic institutions and government organizations, the company said.

https://news.yahoo.com/zoetis-donates-animal-covid-19-133918268.html

Arrowhead Pauses ARO-ENaC Phase 1/2 Clinical Study

 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today notified regulatory agencies, institutional review boards, and investigators that effective immediately it is voluntarily pausing AROENaC1001, a Phase 1/2 clinical study of ARO-ENaC, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with cystic fibrosis (CF), after receiving a preliminary update from an ongoing chronic toxicology study in rats that contained unexpected signals of local lung inflammation. The company has instructed investigators to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC pending additional data from the ongoing chronic rat toxicology study and an additional ongoing chronic primate toxicology study.

Javier San Martin, M.D., chief medical officer at Arrowhead, said: "The safety of patients that participate in clinical trials of our investigational medicines is paramount to us at Arrowhead. While we have not seen any concerning safety or tolerability signals in subjects enrolled in the AROENaC1001 study, out of an abundance of caution we have decided to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC in the study while we await additional information from ongoing nonclinical toxicology studies. After we receive the full data from these studies, we will assess whether there is an acceptable path forward for further clinical investigation. While we determine our next steps with ARO-ENaC, we look forward to continued progress with the other 8 clinical drug candidates in our pipeline as well as our rapidly expanding preclinical initiatives, including additional lung-targeted programs."

https://finance.yahoo.com/news/arrowhead-pauses-aro-enac-phase-113000317.html

EQT, Goldman near deal to buy contract-research firm Parexel for nearly $9B

 EQT AB and Goldman Sachs Group Inc's investment arm are in advanced talks to buy contract research company Parexel International Corp for nearly $9 billion including debt, the Wall Street Journal reported on Thursday.

The sale to EQT and Goldman could be completed this week, the report said https://www.wsj.com/articles/eqt-and-goldman-near-deal-to-buy-parexel-11625185563?mod=latest_headlines, citing people familiar with the matter.

https://finance.yahoo.com/news/eqt-goldman-near-deal-buy-005128713.html

Iterum Says FDA Found Deficiencies in Drug Application

 Iterum Therapeutics Plc said Thursday that U.S. regulators have found deficiencies in its review of a drug that the company is developing.

The U.S. Food and Drug Administration's findings relate to sulopenem etzadroxil/probenecid, a candidate drug to treat urinary tract infections. The deficiencies found "preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time," Iterum said. The company added that the FDA didn't provide further details about the deficiencies.

Iterum said it plans to work with the FDA to resolve the deficiencies.

https://www.marketscreener.com/quote/stock/ITERUM-THERAPEUTICS-PLC-43499891/news/Iterum-Says-FDA-Found-Deficiencies-in-Drug-Application-35775196/

FDA Accepts Filing of HUTCHMED NDA for Surufatinib to Treat Advanced Neuroendocrine Tumors

 U.S. FDA Accepts Filing of HUTCHMED's NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

- U.S. FDA has assigned a target action date of April 30, 2022 -

- If approved, surufatinib would be HUTCHMED's first novel oncology drug marketed outside of China -

HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration ('FDA') has accepted its filing of the New Drug Application ('NDA') for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ('NETs'). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.

Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: 'This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide. The FDA's acceptance of the NDA highlights the clinical value of this submission package and the importance of bringing more treatment options to US NET patients.'

The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p¹ and SANET-ep² both previously reported in The Lancet Oncology), and a surufatinib study conducted in the U.S.³ The data package will also be used to file a Marketing Authorization Application ('MAA') to the European Medicines Agency ('EMA') imminently, based on scientific advice from the EMA's Committee for Medicinal Products for Human Use.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

https://www.marketscreener.com/quote/stock/HUTCHMED-CHINA-LIMITED-59660104/news/HUTCHMED-China-nbsp-U-S-FDA-Accepts-Filing-of-HUTCHMED-s-NDA-for-Surufatinib-for-the-Treatment-of-35775529/

Glaxo rejects activist Elliott's demands for board and consumer business

 

GSK's board on Friday rejected Elliott's demands that the British company change its board and sell its consumer healthcare arm after separating it from its pharma business, a day after strongly worded proposals from the activist investor.

"The Board strongly believes Emma Walmsley is the right leader of New GSK and fully supports the actions being taken by her and the management team," GSK said on Friday, referring to the core pharmaceuticals and vaccine business.

It added that support for GSK's strategy and leadership was shown in talks with its largest shareholders.

In a letter to GSK's board, Elliott on Thursday said GSK should review its leadership and consider a sale of its consumer healthcare business as it confirmed it had taken a significant stake in the group.

Elliott demanded that directors with more "biopharmaceuticals and scientific experience" be added to GSK's board before the planned break-up of the company next year. That new board should then decide the best executive leadership, it added.

GSK responded by stating that governance and oversight had been strengthened with the appointment of two new non-executive directors over the last 18 months, and that more biopharmaceutical expertise was on its way with even more appointments, saying this had been flagged previously.

The British drugmaker also defended its decision to transfer majority ownership in the consumer business to its shareholders in a demerger, combined with plans to sell a minority stake in the business in the near future.

"The demerger structure reflects feedback from a significant proportion of GSK's shareholders that they wish to own Consumer Healthcare as a new listed entity," GSK wrote.

Elliott had urged GSK to look at a full sale of the consumer health business, which is a joint venture with Pfizer, should the opportunity arise.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/GSK-rejects-activist-Elliott-s-demands-for-board-and-consumer-business-35774874/

J&J COVID-19 vaccine shows promising early signs of protecting against Delta variant

 Johnson & Johnson’s COVID-19 vaccine showed promising signs in a small laboratory study of protecting against the Delta variant spreading across the U.S. and other countries, the company said.

In laboratory testing, the vaccine triggered strong levels of neutralizing antibodies in blood samples taken from eight vaccinated people, J&J said Thursday.

The positive performance adds to a growing set of evidence indicating currently authorized Covid-19 vaccines can safeguard against the Delta variant, which appears to be more contagious than earlier strains.

How well the J&J shot fares against the Delta variant has been closely watched by health authorities around the world.

Many countries have been counting on supplies, especially because the vaccine is simpler to ship, handle and store than the shots from Pfizer Inc. and its partner BioNTech SE and from Moderna Inc.

Ticker	Security	Last	Change	Change %
JNJ	JOHNSON & JOHNSON	165.96	+1.22	+0.74%
PFE	PFIZER INC.	39.56	+0.40	+1.02%
MRNA	MODERNA, INC.	235.11	+0.13	+0.06%
AZN	ASTRAZENECA PLC	60.31	+0.41	+0.68%

The new findings "reinforce the ability of the Johnson & Johnson COVID-19 vaccine to help protect the health of people globally," said J&J Chief Scientific Officer Paul Stoffels.

J&J also said its vaccine provides protection against COVID-19 for at least eight months, the most time that researchers were able to study the shot’s durability.

The Delta variant first emerged in India late last year. Since then, it has spread rapidly, becoming the most common strain of the COVID-19 virus in several countries, including the U.S.

The variant made up about 40% of positive COVID-19 test samples as of June 27, according to population genomics company Helix OpCo LLC, which collects and analyzes test samples from several U.S. states.

Vaccination is the best defense against the Delta variant, according to public-health authorities, who have cited the threat posed by the strain in urging people to get immunized.

So far, studies have indicated various vaccines appear effective against the Delta strain, especially once individuals have been fully vaccinated, though the shots aren’t as protective as they are against the original virus.

Separate studies in England and Scotland found that vaccines from Pfizer-BioNTech and AstraZeneca PLC offered substantial protection from the Delta variant against severe cases of Covid-19 and hospitalization.

England’s public health agency said an analysis of 14,000 cases found the Pfizer-BioNTech shot reduced the risk of hospitalization after infection with Delta by 96%.

J&J’s single-dose shot is based on a different technology than the Pfizer-BioNTech and Moderna vaccines, but operates similar to AstraZeneca’s.

J&J’s shot uses a modified version of the virus responsible for the common cold, to carry genetic instructions teaching cells how to make the spike protein that juts from the surface of the coronavirus.

Production of the spike protein, in turn, prompts the immune system to develop molecular defenses against the coronavirus.

In its large, pivotal study, the J&J vaccine was 66% effective in protecting against severe disease, though it appeared to be less effective against the variant first found in South Africa, now called Beta.

Overall, however, it was highly effective in places where variants were spreading during the trial. The U.S. Food and Drug Administration authorized the shot in February.

J&J said the neutralizing-antibody activity found in its recent laboratory study was higher for the Delta variant than for Beta.

https://www.foxbusiness.com/healthcare/jj-covid-19-vaccine-shows-promising-preliminary-signs-of-protecting-against-delta-variant