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☆ F.D.A. Approves New Drug to Treat Hot Flashes
▼ + stars: | 2023-05-12 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Background: Symptoms have long been enduredHot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said. And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere. Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. What’s Next: The drug price may be prohibitiveAstellas said that the drug would cost $550 for a 30-day supply, not including rebates.

☆ It's riskier than ever to be a foreign business in China, as evidenced by a series of recent sanctions, detentions, and an updated anti-espionage law that has watchdogs on edge
▼ + stars: | 2023-05-08 | by ( Huileng Tan | ) www.businessinsider.com time to read: +5 min

The updated law doesn't clearly define what constitutes China's national security or interests. The new law follows a recent spate of sanctions, probes, and detentions into foreign firms in China. Even now, the terms relating to national security and interest are still "not explicitly defined," the Eurasia Group wrote. The updated law is also particularly concerning because of the recent developments surrounding foreign firms in China. China's recent crackdown on foreign businesses is spurring concernsIn April, Chinese police questioned staff at American consultancy Bain in Shanghai.

☆ The end of cheap credit could hurry Japanese M&A
▼ + stars: | 2023-05-02 | by ( ) www.reuters.com time to read: +2 min

Diversifying abroad looks attractive to many Japanese companies given weak home markets. The country's third-largest drugmaker by sales is paying a modest-looking 22% premium to Iveric's share price before the announcement. Analysts at Jefferies reckon those sales could top $85 million in its first year and peak at $2.4 billion annually by 2034. Regardless, even Warren Buffett has taken advantage of Japanese rates to funds deals inside Japan; domestic corporations looking abroad will as well. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

☆ Astellas Pharma buys Iveric Bio for $5.9 billion
▼ + stars: | 2023-05-01 | by ( ) www.reuters.com time to read: +1 min

May 1 (Reuters) - Japan's Astellas Pharma (4503.T) said on Monday it agreed to buy U.S.-based drugmaker IVERIC Bio Inc for about $5.9 billion in its biggest acquisition, giving it access to a range of ophthalmology treatments. Through Berry Merger Sub Inc, a wholly-owned subsidiary of Astellas U.S. Holding, the Japanese company agreed to acquire IVERIC for $40 per share in cash, Astellas said in a release. The acquisition price is a 22% premium to IVERIC's $32.89 closing price on April 28. Prior to that, its biggest ever acquisition was its $3.8 billion purchase of OSI Pharmaceuticals Inc in 2010. Reporting by Baranjot Kaur in Bengaluru; Editing by Kim CoghillOur Standards: The Thomson Reuters Trust Principles.

☆ In China, a Detention and a New Espionage Law Have Businesses Worried
▼ + stars: | 2023-04-28 | by ( Yoko Kubota | Miho Inada | ) www.wsj.com time to read: 1 min

China’s detention of a Japanese executive at Astellas Pharma is one of a string of incidents that have sparked new concerns among foreign companies. Photo: Akio Kon/Bloomberg NewsBEIJING— Hiroshi Nishiyama , a veteran Japanese executive at Astellas Pharma Inc. and a prominent member of his country’s business circle in China, spent late March wrapping up his assignment there and preparing to head home. He never made it. Mr. Nishiyama disappeared on what was supposed to be his last day in China. A few days later, China’s Foreign Ministry said he had been accused of espionage and detained.

The revision is likely to heighten concerns of foreign individuals, such as academic researchers or journalists, and businesses about visiting or operating in China. “Something like a local government budget you could broadly define as relating to national security, or even food security,” he said. “Researchers definitely need to be careful.”China says its laws related to national security and espionage are meant to safeguard the country. “Even with this amendment we still don’t understand what kind of document constitutes a national security issue,” he added. Chinese authorities did not offer details about both cases, including the reason for the crackdown, but analysts say the move is likely to further spook foreign businesses operating in China.

☆ Japan will keep calling for China to act responsibly, Kishida says
▼ + stars: | 2023-04-20 | by ( Yukiko Toyoda | ) www.reuters.com time to read: +3 min

TOKYO, April 20 (Reuters) - Japan will keep calling for China to act responsibly on the world stage, Prime Minister Fumio Kishida said on Thursday, a sign of Tokyo's deepening concern about stability in the Taiwan Strait following Beijing's recent military drills. The comments from Kishida, after China conducted drills in the waters off Taiwan earlier this month, highlight Tokyo's growing alarm about the possibility of an attack on nearby Taiwan. Japan would "continue to call on China to take the responsibility it should be taking as a major country on the world stage," Kishida said during a roundtable interview with members of the foreign media. Japan has joined the United States in putting export restrictions on chip-making tools but in doing so avoided mentioning China so as not to antagonise its neighbour. Kishida also said Japan was calling on China to allow for the return of a Japanese executive detained there.

☆ Japan PM strongly demands Beijing release detained Astellas employee
▼ + stars: | 2023-04-03 | by ( ) www.reuters.com time to read: 1 min

TOKYO, April 3 (Reuters) - Japan's Prime Minister Fumio Kishida said on Monday the government will continue to strongly demand Beijing for an early release and consular visits for an Astellas Pharma (4503.T) employee detained in China. The government would also provide as much support as possible, including contacting his family, Kishida told an Upper House budget committee meeting. Kishida's comments came after the country's foreign minister Yoshimasa Hayashi met his Chinese counterpart on Sunday and urged China to promptly release the detained JapaneseReporting by Mariko Katsumura; Editing by Jacqueline WongOur Standards: The Thomson Reuters Trust Principles.

TOKYO/BEIJING, April 2 (Reuters) - Japan's foreign minister Yoshimasa Hayashi said he called on Beijing for the early release of a detained Japanese national during a meeting with Chinese diplomat Qin Gang held on Sunday. The visit comes a week after a spokesperson of Astellas Pharma Inc (4503.T) said its employee was detained in China for unknown reasons. Although Japan and China have their differences, both agreed to restart trilateral talks with South Korea, Hayashi said, calling the agreement "an important achievement" from his meeting with Qin. "We agreed to continue communicating closely on various levels, including the foreign ministerial and leadership levels," Hayashi added. Japanese Prime Minister Fumio Kishida and Chinese President Xi Jinping met on the sidelines of the Asia-Pacific Economic Cooperation (APEC) summit last November, marking the first leadership-level talks in almost three years.

☆ Japan foreign minister Hayashi to visit Beijing on Saturday
▼ + stars: | 2023-03-31 | by ( ) www.reuters.com time to read: +2 min

TOKYO, March 31 (Reuters) - Japan Foreign Minister Yoshimasa Hayashi said on Friday he will visit Beijing for two days from Saturday to discuss a range of issues, including the detention of an Astellas Pharma Inc (4503.T) employee. Hayashi told reporters he will meet with Chinese Foreign Minister Qin Gang during the visit for "an honest and frank discussion to create a constructive and stable relationship". Hayashi's visit to China follows leadership-level talks held on the sidelines of an international summit last November, the first between the two countries in almost three years. At the time, Japanese Prime Minister Fumio Kishida said he conveyed his concerns over China's increasing maritime military presence but also said the two leaders agreed to reopen diplomatic channels of communications including a visit by Japan's foreign minister to China in the near future. Reporting by Sakura Murakami and Rocky Swift; Editing by Shri Navaratnam and Sonali PaulOur Standards: The Thomson Reuters Trust Principles.

☆ Japanese man detained in China is Astellas Pharma employee
▼ + stars: | 2023-03-26 | by ( ) www.reuters.com time to read: +1 min

TOKYO, March 26 (Reuters) - A Japanese man detained in China is an employee of Astellas Pharma Inc (4503.T), a company spokesperson told Reuters on Sunday. The company did not identify the employee and the spokesperson said it was not clear as to why he had been detained. Kyodo and other Japanese media reported on Saturday that a Japanese man in his 50s was taken into custody in Beijing this month for an alleged violation of Chinese law. But China had not fully explained what prompted authorities in Beijing to detain the man, media said. The Japanese government had asked Chinese authorities to release the man, media reported.

☆ US declines to force lower price on cancer drug Xtandi
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, March 21 (Reuters) - The U.S. government will not force Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency "march-in" authority, the National Institutes of Health (NIH) said on Tuesday. Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug's price in March 2016. The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available. "NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," the letter said. Progressive lawmakers in the Democratic Party have been calling on President Joe Biden's administration to use its march-in authority to lower drug prices.

[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.

☆ Merck scraps third prostate cancer study as Keytruda therapy disappoints
▼ + stars: | 2023-02-28 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

The setbacks were likely to put Merck further behind in its quest to develop a treatment for advanced forms of the most common cancer type in the United States. It had in January stopped a late-stage study of the drug in some prostate cancer patients. An interim analysis showed the combination therapy did not extend survival or help extend the time a patient lives without the disease worsening compared to placebo, Merck said. Merck was testing its blockbuster immunotherapy in combination with androgen deprivation therapy and Xtandi, made by Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T), in patients with an advanced form of treatment-resistant prostate cancer. Additionally, Merck said another combination treatment with Keytruda did not meet the main goal in a separate late-stage study for a type of lung cancer that can spread to other parts of the body.

☆ Merck scraps Keytruda trial for prostate cancer after dismal interim data
▼ + stars: | 2023-01-25 | by ( ) www.reuters.com time to read: +1 min

Jan 25 (Reuters) - Merck & Co Inc (MRK.N) said on Wednesday it was discontinuing a late-stage trial of its blockbuster immunotherapy Keytruda in some prostate cancer patients after interim data showed it was unlikely to meet the study's main goals. The interim analysis showed the therapy did not extend survival or help extend the time a patient lives without the disease worsening, the U.S. drugmaker said. The trial had enrolled 1,251 patients who received the combination therapy with Keytruda or a placebo. Prostate cancer is the most common cancer in the United States with nearly 270,000 new cases and 34,500 deaths in the country in 2022, according to government data estimates. Separately, Merck said Keytruda in combination with a chemotherapy showed significant improvement in overall survival in patients with an advanced type of bile duct cancer.

☆ Biotech investor Brad Loncar shares 10 predictions for 2023, including a hot new cancer target, Nobel Prize winners, and a biotech founder running for president
▼ + stars: | 2023-01-04 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +14 min

Loncar shared his 2023 forecast, including new drugs, Nobel Prize winners, and more globalization. Brad Loncar isn't expecting a miraculous rebound for the biotech industry in 2023. In an interview with Insider, Loncar shared 10 predictions for biotech in 2023, ranging from Nobel Prize winners and presidential runs to hot cancer targets and bankruptcy worries. 2022 was a rough year for the biotech industry, which once again underperformed the stock market. The industry runs to the next super-hot cancer target: Claudin 18.2In cancer research, drug companies are always on the hunt for the next promising target.

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