Health News Roundup: J&J in talks to buy Shockwave Medical, WSJ reports; Japan warns on surge in potentially deadly strep throat cases and more

Bengaluru-based medical technology company Wipro GE Healthcare said on Tuesday the investment would be done over the next five years to boost local manufacturing as it focuses on growing its footprint in the country in line with the government's "Make in India" initiative.

Following is a summary of current health news briefs.

Regeneron's blood cancer therapy faces setback as FDA raises trial concerns

Regeneron Pharmaceuticals said on Monday the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma on concerns over the progress of ongoing confirmatory trials. The FDA said in its response letter that it needs more data from enrollments in dose-finding and confirmatory portions of trials, delaying its decision on the drug, while confirming no issues with clinical efficacy or safety, trial design, labeling or manufacturing.

BioNTech gets US agency notice over default on COVID vaccine royalties

BioNTech said on Monday the U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine. BioNTech, which partnered with U.S. pharma giant Pfizer for its COVID-19 vaccine, however, said it disagreed with the positions being taken by the NIH and intends to defend against all allegations of breach.

J&J in talks to buy Shockwave Medical, WSJ reports

Johnson & Johnson is in talks to buy medical device maker Shockwave Medical, the Wall Street Journal reported on Tuesday, as the healthcare giant potentially looks to expand its presence in cardiovascular devices. Shockwave, a company that makes devices to treat heart disease, has a market capitalization of around $11 billion, according to LSEG data.

US Supreme Court appears skeptical of challenge to abortion pill access

The U.S. Supreme Court on Tuesday signaled that it is unlikely to limit access to the abortion pill as the justices appeared skeptical that the anti-abortion groups and doctors that are challenging the drug have the needed legal standing to pursue the case. The justices heard arguments in an appeal by President Joe Biden's administration of a lower court's ruling in favor of the plaintiffs that would limit how the medication, called mifepristone, is prescribed and distributed. The case places reproductive rights back on the Supreme Court's agenda in a presidential election year.

Japan warns on surge in potentially deadly strep throat cases

Japanese health authorities have warned about a jump in potentially deadly strep throat infections, with cases running about three times higher than last year in Tokyo. Across the country, infections of streptococcus bacteria of the throat are being diagnosed at quadruple the pace of the past five years, according to a health ministry report earlier this month.

Gene therapy maker bluebird to revise financials after accounting errors

Gene therapy maker bluebird bio said on Tuesday it plans to revise its financial statements for 2022 and the first three quarters of last year due to accounting errors related to some contract manufacturing agreements. The company said it has identified "material weakness in its internal control over financial reporting", and will take time till April 16 to file its 2023 annual report that was expected this month.

Exclusive - US lawmaker seeks answers on FDA inspection of Musk's Neuralink

A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk's Neuralink before allowing the brain implant company to test its device in humans. Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than a month after the startup said it was cleared to test its brain implants in humans.

PE firm Olympus to sell up to $235 million stake in India's Aster DM, term sheet shows

Private equity firm Olympus Capital Asia plans to sell a 9.8% stake in India's Aster DM Healthcare for up to 19.53 billion rupees (nearly $235 million), according to a term sheet seen by Reuters on Tuesday. Olympus Capital, which owns about 19% stake in the hospital chain, is planning the sale at 400-437.20 rupees per share. The low end of the range represents an 8.5% discount to the Aster DM stock's last close and no discount at the upper range.

Wipro GE Healthcare to invest $960 million in R&D, manufacturing in India

Wipro GE Healthcare, a joint venture of India's Wipro Enterprises and a wholly owned entity of U.S.-based GE Healthcare, said it would invest 80 billion rupees ($960 million) in the country in its manufacturing and research and development facilities. Bengaluru-based medical technology company Wipro GE Healthcare said on Tuesday the investment would be done over the next five years to boost local manufacturing as it focuses on growing its footprint in the country in line with the government's "Make in India" initiative. As part of the investment, the company will manufacture its PET CT diagnostic scan devices in India for export to 15 countries, it said. A PET CT (positron emission tomography and computed tomography) scan, used in the treatment of illnesses such as cancer, is a combination of imaging methods to understand the functioning of the body up to the cellular level. Wipro GE Healthcare's other high-end medical technology devices such as its CT scanners and MR breast coils will also be manufactured in India, the company said in a statement."As India envisions to be among the top five global manufacturing hubs in terms of value and technology for medical devices in the coming years, we are committed to the national healthcare agenda," Wipro GE Healthcare Managing Director Chaitanya Sarawate said. The company, established in 1990, started a greenfield manufacturing unit in 2022 in the southern Indian city of Bengaluru as part of the government's production-linked incentive scheme. The scheme is a financial incentive for companies to encourage local investments and manufacturing. The company, which has four manufacturing plants in Bengaluru, also known as India's Silicon Valley, focusing on export services, said it would continue to invest in India and expand its global footprint.

Viking Therapeutics' weight-loss tablet shows promise in small study

Viking Therapeutics' experimental tablet reduced weight by as much as 3.3% when tested in volunteers enrolled in a small early-stage trial, meeting Wall Street expectations and sending the company's shares up 15% in premarket trading on Tuesday. Popular market leaders from Eli Lilly and Novo Nordisk are administered under-the-skin, with companies also testing oral versions that they hope will offer patients a more convenient option.

(With inputs from agencies.)