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Dec 28 (Reuters) - TG Therapeutics Inc (TGTX.O) said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up nearly 9% in afternoon trade. TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing. Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to neurological disease.

☆ Roche's head of pharmaceuticals to leave company
▼ + stars: | 2022-12-12 | by ( ) www.reuters.com time to read: +1 min

ZURICH, Dec 12 (Reuters) - Roche's (ROG.S) head of its pharmaceuticals division will leave the drugmaker at the end of the year, the Swiss company said on Monday, as it confirmed other parts of its succession plan. Former Genentech boss Bill Anderson "has decided to pursue opportunities outside of Roche," Roche said, with a successor due to be named by March 2023. Schinecker will replace Severin Schwan, who is slated to become chairman after 14 years as CEO of Roche. He has been instrumental in shaping Roche’s transformation and I wish him all the best for the future," Schwan said in a statement. He had been CEO of Roche's pharmaceuticals business since 2019.

☆ Britain's NICE recommends against NHS use of 5 COVID treatments as not cost-effective
▼ + stars: | 2022-11-16 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

The review, conducted by the National Institute for Health and Care Excellence (NICE) and published on Wednesday, is its first involving COVID-19 treatments as the pandemic enters a new phase. The recommendations are a draft, NICE said, and until final guidance is published, access to COVID-19 medicines will continue as is. NICE acknowledged that there is evidence that Merck's molnupiravir and Gilead Sciences Inc's (GILD.O) hospital-administered antiviral remdesivir are effective at treating COVID-19. It also recommended against three other COVID treatments, including GSK (GSK.L) and partner Vir Biotechnology's (VIR.O) sotrovimab, an antibody therapy that the World Health Organization recommended against in September. One expert said that some of the COVID treatments NICE recommended against are an important part of the British government's current strategy.

☆ U.S. FDA authorizes Roche's monkeypox test
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: 1 min

Nov 15 (Reuters) - The U.S. Food and Drug Administration on Tuesday issued an emergency use authorization to Roche's (ROG.S) monkeypox test. Reporting by Leroy Leo in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

The comments follow a softer-than-expected inflation report last week, which had buoyed hopes that the Fed could scale back its hefty interest rate hikes and helped drive a euphoric market rally. The S&P 500 in the previous session logged its biggest weekly percentage gain in about five months, while the tech-heavy Nasdaq (.IXIC) notched its best week since March. "The market is expecting the Fed to continue its hawkish rhetoric on rates. ET, the S&P 500 (.SPX) was down 17.25 points, or 0.43%, at 3,975.68, and the Nasdaq Composite (.IXIC) was down 115.13 points, or 1.02%, at 11,208.20. The S&P 500 information technology sector (.SPLRCT) was down 1.2% and among the leading sectoral decliners on the benchmark index.

The comments follow a softer-than-expected inflation report last week, which had buoyed hopes that price pressures were easing and the Fed could scale back its hefty interest rate hikes. "The market is expecting the Fed to continue its hawkish rhetoric on rates," said Peter Cardillo, chief market economist at Spartan Capital Securities. Once they (Fed) raise rates at 50 (bps), there's a possibility that they might indicate slower rates." Traders now expect the Fed to hike interest rates in December by a half point, and expect terminal rate in the range of 4.75%-5.0% next year. ET, Dow e-minis were down 50 points, or 0.15%, S&P 500 e-minis were down 11.5 points, or 0.29%, and Nasdaq 100 e-minis were down 62 points, or 0.52%.

☆ Roche's Alzheimer's drug fails to meet goal in long awaited trial
▼ + stars: | 2022-11-14 | by ( Ludwig Burger | ) www.reuters.com time to read: +4 min

Nov 14 (Reuters) - Roche said (ROG.S) its Alzheimer's drug candidate could not clearly be shown to slow dementia progression in two drug trials, failing to draw level with a recent development success by rivals Biogen (BIIB.O) and Eisai (4523.T). Within each study, volunteers were randomly assigned to receive either the injectable antibody drug gantenerumab or a placebo. The quest to develop an Alzheimer's drug, targeting beta-amyloid or other molecules, has been beset by a long list of study failures. But rival Biogen in September scored a surprise trial success with an experimental Alzheimer's drug that it developed with Eisai, rebuilding confidence among industry executives and researchers in the beta-amyloid approach. Schwan earlier this year sought to curb expectations for the Graduate trials but the head of Roche's pharma unit last month acknowledged that Biogen's success with lecanemab had reignited hopes.

☆ Roche's Alzheimer drug failing was a tailwind for a Biogen rally, Mizuho's Salim Syed
▼ + stars: | 2022-11-14 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailRoche's Alzheimer drug failing was a tailwind for a Biogen rally, Mizuho's Salim SyedSalim Syed, Mizuho senior biotech analyst, joins 'Closing Bell' to discuss Biogen stock ticking up after Roche's new Alzheimer's drug didn't meet its goals.

☆ A top Wall Street analyst names 6 major events that could send biotech stocks soaring between now and the end of 2022
▼ + stars: | 2022-11-14 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +5 min

Cantor Fitzgerald analysts named six big events to mark on your calendar. While the majority of the expected events are set to come from smaller biotech companies, bigger companies — like Roche, Gilead, and Alnylam — have their own events coming through the pipeline. Here are the six major events from big biotech companies that could send stocks soaring:1. Cantor Fitzgerald analysts give Gilead's stock a neutral rating and they have an overweight rating on Arcus. Lenacapavir "could become a much bigger piece of the HIV growth narrative over the next few years," according to Cantor Fitzgerald analysts.

☆ Stocks making the biggest moves in the premarket: Hasbro, Oatly, Advanced Micro Devices and more
▼ + stars: | 2022-11-14 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Advanced Micro Devices (AMD) – The chip maker's stock rose 3.2% in the premarket after receiving upgrades at both Baird and UBS. Amazon.com (AMZN) – Amazon fell 1.7% in premarket trading after Bank of America removed the stock from its "US 1" list, although it maintained a "buy" rating. Teva Pharmaceutical (TEVA) – Teva was downgraded to "underweight" from "neutral" at J.P. Morgan Securities, which cited continuing growth challenges for the drugmaker. Teva fell 2.3% in premarket action. Lilly added 1.5% in premarket trading, while Biogen rallied 5.8%.

☆ Stocks making the biggest moves midday: Oatly, Amazon, Hasbro and more
▼ + stars: | 2022-11-14 | by ( Carmen Reinicke | ) www.cnbc.com time to read: +3 min

Oatly – Shares of the oat-based drinks maker tumbled 11% after the company reported a larger-than-expected quarterly loss and revenue that fell short of consensus. Oatly cited China Covid restrictions, production challenges and a stronger U.S. dollar for the weakness in its performance. Amazon – Amazon fell 1.4% following a report that it plans to lay off about 10,000 employees as soon as this week. The cuts would be the largest in the company's history, and would primarily affect Amazon's devices organization, retail division and human resources, according to The New York Times. Cloud stocks – Cloud stocks slipped Monday as investors took gains off the table.

☆ Goldman upgrades Biogen, says it’s poised to address early Alzheimer’s market next year
▼ + stars: | 2022-10-26 | by ( Tanaya Macheel | ) www.cnbc.com time to read: +2 min

Biogen shares have a lot more potential upside for investors thanks to positive new data around the company's early Alzheimer's drug, Goldman Sachs said Wednesday. The upgrade followed the company's earnings call, which had a big focus on the drug, lecanemab, an anti-amyloid antibody that is in phase 3 trials. Goldman also raised its revenue estimates for the drug to $14 billion in 2035, compared with prior estimates of $2 billion. "The company is now poised to address the early Alzheimer's disease market in 2023+ following the recent topline lecanemab Ph3 (CLARITY-AD) data," Goldman analyst Salveen Richter said in a note. "With BIIB shares now trading at ~$270 post the topline CLARITY-AD data, there is roughly ~$80/share reflected in the stock for Alzhiemer's disease," Richter said.

☆ Roche sales decline more than expected as COVID products slide
▼ + stars: | 2022-10-18 | by ( Ludwig Burger | Nancy Lapid | ) www.reuters.com time to read: +2 min

Third-quarter revenue slipped to 14.74 billion Swiss francs ($14.84 billion), below market expectations of about 15.5 billion francs. Its bestseller Ocrevus gained 16% in sales to 1.52 billion francs during the quarter, while Hemlibra jumped 23% to 952 million francs, both excluding the effect of currency swings. However, analysts at brokerage Jefferies said sales gains in Hemlibra and cancer immunotherapy Tecentriq fell short of market expectations. It also reiterated that the percentage gain in core earnings per share would be in the "low- to mid-single digit" range. Roche repeated that keenly awaited trial data on experimental Alzheimer's drug gantenerumab was due to be published at the end of November.

☆ Analysis: Alzheimer's drug trial breakthrough boost for Roche, Eli Lilly
▼ + stars: | 2022-09-28 | by ( Natalie Grover | ) www.reuters.com time to read: +5 min

Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. Nearly all Alzheimer's drugs, including those targeting amyloid, have stumbled in trials. Late-stage data on gantenerumab is expected by the fourth quarter, Roche said in a statement, saying it was encouraged by the lecanemab data. Results of a key late-stage trial testing the drug are anticipated by mid-2023. AMYLOID HYPOTHESISSome researchers, including Frederiksen, are cautiously optimistic about the impact the Biogen, Eisai data has on the likelihood of success for the other two drugs in development.

The trial results released on late Tuesday could mark a rare victory in the search for a treatment for the memory-robbing disease after years of clinical failures. Biogen's stock surged 46.6% to $290.99 in premarket trading, putting it on track to add over $13.5 billion in market capitalization. BMO analyst Evan Seigerman called the data an "unequivocal win" for Biogen and Alzheimer's patients. The latest trial boost for Biogen and Eisai's lecanemab has raised hope for success in trials testing Roche's gantenerumab and Lilly's donanemab. Shares of smaller Alzheimer's drug developers also rose in premarket U.S. trading.

☆ WHO 'strongly advises against' use of two COVID treatments
▼ + stars: | 2022-09-15 | by ( Natalie Grover | ) www.reuters.com time to read: +3 min

A woman holds a small bottle labelled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken October 30, 2020. The virus has since evolved, and mounting evidence from lab tests suggests the two therapies - sotrovimab as well as casirivimab-imdevimab - have limited clinical activity against the latest iterations of the virus. Another COVID therapy that emerged early in pandemic was Gilead's (GILD.O) antiviral remdesivir. The WHO expanded its conditional recommendation for the drug, advising that it can be used in patients with severe COVID as well as non-severe COVID patients at the highest risk of hospitalization. There are a handful of existing COVID therapeutics that remain useful in the fight against the virus, and others in development that are expected to also benefit patients.

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