A Tsunami that could reach a height of up to 3 meters is expected to hit Japan's Pacific coast, following an earthquake of 7.6 magnitude, the Japan Meteorological Agency said on Monday.
The agency detailed that the areas at risk are Iwate, Aomori, and parts of Hokkaido. A 40-centimeter tsunami has already been registered in Aomori, as well as Hokkaido.
Alerts for evacuation have been sounded in the areas.
Viatris (VTRS) on Saturday said that it has entered into definitive agreements with Biocon for the sale of Viatris' equity stake in Biocon Biologics Limited.
Under the definitive agreements, Biocon will acquire all of Viatris' (VTRS) convertible preferred equity in Biocon Biologics for total consideration of $815 million, consisting of $400 million in cash and $415 million in newly issued equity shares of Biocon.
The shares are subject to a six-month lock-up period.
Transaction value will be subject to related taxes.
In addition, the terms of the definitive agreements accelerate the expiration of biosimilars non-compete restrictions previously placed on Viatris in 2022 in connection with Viatris' sale of its biosimilars portfolio and related commercial and other capabilities to Biocon Biologics.
These restrictions will expire immediately at the time of close for all ex-U.S. markets and in November 2026 for U.S. markets. The transaction is expected to close in Q1 2026.
Oppenheimer’s Chief Investment Strategist John Stoltzfus reportedly expects the S&P 500 index to rally by 18% by the end of 2026, rising to 8,100 points.
According to a Bloomberg report citing Stoltzfus’s latest note, the strategist expects the S&P 500 to surge on the back of easing monetary policy and robust economic growth.
One of Wall Street’s widely followed strategists, Stoltzfus, said the firm is positive on equities and considers it its favorite asset class, according to the report. In addition to the Fed’s rate cuts and economic resilience, the strategist also credited strong U.S. corporate earnings as a reason behind his bullish outlook on the S&P 500 heading into the next year.
The S&P 500 has soared 17% year-to-date, and Lance Roberts, Chief Strategist at RIA Advisors, noted in a post on X that seasonality has turned supportive. He pointed to the index’s historical performance since 1928, noting that it has delivered an average gain of 1.3% in the second half of December. The gains stood at 2.1% when the seasonality was supportive, he observed.
In a note last week, Stoltzfus stated that if the Fed does cut rates this month, the markets are likely to reflect on it positively, if not enthusiastically. “In 2026 we expect the Fed will likely cut rates further if the flow of economic data suggests that inflation is slowing or if the unemployment rate rises further,” he added.
In July, Stoltzfus revised the year-end target for the S&P 500 index to 7,100 from 5,950. With three weeks to go for the end of 2025, the index is just 3% shy of the firm’s target.
Veteran analyst Ed Yardeni, President of Yardeni Research, said in a recent note that U.S. equities are set for an early Santa Claus rally amid rising hopes of a rate cut.
“The S&P 500 rose back above its 50-day moving average last week and now appears to be back on track to hit 7,000 in a year-end Santa Claus rally,” he said.
According to data from the CME FedWatch tool, there is a 89.6% probability of a 25-basis-point rate cut this week.
Meanwhile, U.S. equities gained in Monday’s pre-market trade. At the time of writing, the SPDR S&P 500 ETF (SPY), which tracks the S&P 500 index, was up by 0.17%. Retail sentiment around the S&P 500 ETF on Stocktwits was in the ‘bearish’ territory.
On December 8, 2025, STAAR Surgical Company announced the expiration of its go-shop period, which ended on December 6, 2025, as part of its amended merger agreement with Alcon Inc. During this period, STAAR actively solicited acquisition proposals from 21 third parties but received no competing offers, validating the effectiveness of its board’s sale process. The outcome discredits allegations from Broadwood Partners, L.P. about ignored acquisition interest, confirming Alcon as the best buyer for STAAR.
The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to market more quickly and easily.
In line with its deregulatory stance under new Commissioner Marty Makary, the US regulator has launched TEMPO – Technology-Enabled Meaningful Patient Outcomes – that will take the form of a voluntary pilot scheme "designed to promote access to certain digital health devices while safeguarding patient safety."
The TEMPO pilot will run within the Centers for Medicare and Medicaid Services (CMS) recently launched ACCESS model, which is testing an outcome-aligned payment approach for Medicare aimed at improving access to approved healthtech that is used for people with conditions like high blood pressure, diabetes and prediabetes, chronic musculoskeletal pain, and depression.
The FDA plans to select up to 10 device manufacturers in each of four clinical areas – which have not already gone through the usual premarket authorisation process – in the initial phase of the TEMPO project, and sponsors will be able to submit statements of interest starting in January 2026.
The four areas are early cardio-kidney-metabolic – which includes hypertension, dyslipidaemia, obesity/overweight, and prediabetes – along with later-stage cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease), chronic musculoskeletal pain, and behavioural health interventions of depression or anxiety.
"We are piloting an approach to encourage the use of digital technologies that meet people where they are," said Makary in a statement. "This pilot supports innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease."
According to the regulator, participating manufacturers can request enforcement discretion for certain requirements, such as premarket authorisation and investigational device rules, as long as they target chronic conditions.
The FDA and CMS will work together on the TEMPO pilot, in which participating manufacturers will offer their DHTs for use while "collecting, monitoring, and reporting real-world performance data." The FDA will work with participants to identify the circumstances when enforcement discretion may be appropriate for a particular DHT.
The pilot will "allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives," commented Michelle Tarver, director of the FDA's Center for Devices and Radiological Health (CDRH).
Makary has said he aims to challenge with way medical products are regulated in the US while in office, taking the brakes off a system that he claims is holding the country back in an increasingly competitive international landscape. Other initiatives include the Commissioner's National Priority Voucher programme, which could see some medicines approved in weeks, rather than months, and a recently discussed move towards requiring only one pivotal clinical trial – rather than a pair – as the standard for showing safety and efficacy.
https://pharmaphorum.com/news/fda-reveals-real-world-pilot-digital-health-tools
Gilead Sciences' Kite unit has showcased three new CAR-T therapies at ASH, headed by multiple myeloma candidate anitocabtagene autoleucel (anito-cel) which is being prepared for a filing and potential launch in 2026.
The BCMA-targeted CAR-T could be a competitor to Johnson & Johnson and Legend Biotech's already approved Carvykti (ciltacabtagene autoleucel) and Bristol-Myers Squibb's Abecma (idecabtagene vicleucel) if approved for marketing.
At ASH, Kite presented the results of the iMMagine-1 trial of anito-cel, which met expectations of strong efficacy with an overall response rate (ORR) of 96%, with 74% of patients achieving a stringent complete response (sCR) or complete response (CR), and 95% of patients testing negative for minimal residual disease (MRD). The CAR-T was being tested in patients who had received at least three prior lines of therapy.
Close attention was paid to the safety data from the study, and in particular rates of neurotoxicities, which have been held up as one way for anito-cel to differentiate itself from its rivals, which are respectively approved as second- and third-line options for multiple myeloma.
At the moment, Carvykti is growing faster than Abecma on what is viewed as superior efficacy data, including a higher complete response rate, with quarterly sales currently running above $500 million.
iMMagine-1 showed a rate of neurotoxicity of 8%, and no cases of delayed neurotoxicities like Parkinsonism and neuropathies or immune effector cell-associated enterocolitis (IEC-EC), which are both recognised side effects with J&J and Legend's CAR-T and can happen weeks or months after treatment.
"These data are compelling and are an important advancement for patients living with multiple myeloma," said lead investigator Krina Patel of MD Anderson Cancer Center.
"We rely on therapies that deliver continued meaningful efficacy, a predictable safety profile, and reliable manufacturing," she added." Anito-cel demonstrates that it could become a significant new treatment option in our efforts to improve outcomes for patients."
Anito-cel uses technology developed by Kite's partner Arcellx that is designed to enable high CAR expression, with quick release from the BCMA target, to minimise toxicity. Kite's hope is that its profile will make it suitable for use in outpatient or even community settings.
Bicistronic CAR-Ts
ASH also gave Kite the opportunity to reveal new data on a pair of its so-called 'bicistronic' CAR-Ts, which are designed to target two antigens at the same time. That is a new area of CAR-T therapy that was also explored at ASH in the DURGA-1 study of AstraZeneca's multiple myeloma candidate AZD0120.
Kite reported the results of two CD19 and CD20-directed CAR-Ts – codenamed KITE-753 and KITE-363 – that also include co-stimulatory domains designed to boost their efficacy, reduce cancer cell escape from treatment, and prevent relapse. They can also be produced more quickly than conventional CAR-Ts.
The two studies, both in patients with relapsed/refractory large B-cell lymphoma (LBCL), showed high rates of complete response with KITE-753 (79%) and KITE-363 (70%-plus), with an encouraging safety profile and no dose-limiting toxicities.
https://pharmaphorum.com/news/ash-gilead-preps-filing-anito-cel-immagine-1-data
Dyne Therapeutics’ investigational therapy zeleciment rostudirsen not only increased dystrophin levels in an early Duchenne muscular dystrophy study but also elicited what Stifel analysts called the “best ever” functional improvements for an exon skipper in this indication.
“The regulatory precedent is overwhelmingly in DYN’s favor,” Stifel added, noting that other Duchenne therapies have been approved based on “marginal” dystrophin effects, even with “limited evidence of clinical efficacy.”
While Dyne’s study was not powered to evaluate functional benefits on a statistical level, the analysts confirmed with the company that the analyses for these outcomes “match the rigor/standard of a registrational study.”
In the registrational expansion cohort of Dyne’s Phase I/II DELIVER study, presented Monday, patients given a monthly dose of 20-mg/kg zeleciment rostudirsen (z-rostudirsen) achieved mean dystrophin expression of 5.46% of normal, adjusted for the patients’ muscle content. This finding represents an approximately sevenfold increase in dystrophin at six months, Stifel said, giving z-rostudirsen a “highly differentiated” efficacy profile.
The analysts pointed out that Dyne’s dystrophin figures “far exceed” those of Sarepta Therapeutics’ exon skipper Exondys 51, which they said hit 0.3% of normal at six months. No head-to-head study between Exondys and z-rostudirsen has been conducted, however, and these cross-study comparisons may not accurately capture the relative efficacies of these therapies, Stifel noted.
Beyond dystrophin, patients on z-rostudirsen also saw notable functional improvements at six months—though DELIVER is not powered for statistical assessments of functional benefits versus placebo. A posthoc analysis nevertheless showed that patients on Dyne’s drug had better time-to-rise and 10-meter walk/run outcomes than placebo counterparts, with nominally significant effects. Z-rostudirsen also boosted participants’ stride velocity and upper limb performance, while also improving their lung function.
With these data, Dyne is planning to file a biologics license application for the drug in the second half of 2026, seeking accelerated approval. If all goes well, and if the FDA grants priority review, the biotech is eyeing an early 2027 launch. Also in the back half of next year, Dyne will launch a Phase III program for z-rostudirsen to validate clinical benefit and support global regulatory filings.
