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In 2023, it expects revenue to be $67 billion to $71 billion. Excluding the COVID-19 drugs, Pfizer expects 2023 revenue to grow 7% to 9%. Pfizer developed its COVID-19 vaccine with German partner BioNTech , and the companies split the profits. The U.S. drugmaker forecast 2023 sales of $13.5 billion from the shot, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of Paxlovid, short of analysts' expectation of $10.33 billion. After that transition, the company hopes to roughly quadruple the U.S. price of the COVID-19 vaccine.

☆ Pfizer forecasts weak 2023 sales of COVID products
▼ + stars: | 2023-01-31 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Eric GaillardCompanies Pfizer Inc FollowJan 31 (Reuters) - Pfizer Inc (PFE.N) on Tuesday forecast a steeper-than-expected drop in sales of its COVID-19 vaccine and pills in 2023, intensifying investor concerns over demand for the products as governments reduce orders. The forecast casts some uncertainty over future sales of Pfizer's biggest selling products this year, which are expected to come under pressure as government spending on COVID vaccines and treatments declines. The U.S. drugmaker said it expects sales of $13.5 billion from the vaccine for 2023, below Refinitiv estimates of $14.39 billion, and projected $8 billion in sales of its antiviral pill, Paxlovid, short of analysts' expectation of $10.33 billion. That compared with sales of $37.81 billion for the vaccine and $18.93 billion for Paxlovid in 2022. Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Sriraj Kalluvila and Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Analysts say they have based their 2023 Paxlovid sales estimates primarily on public details of announced deals, with a token amount of estimated China sales from before the country dropped the Zero-COVID policy. Their current estimates for over $10 billion in 2023 Paxlovid sales is less than half the $22 billion Pfizer is expected to report for 2022, according to Refinitiv data. Billions of dollars in Paxlovid sales could be at stake for Pfizer. Even without a deal to sell Paxlovid broadly in China, the company can still sell it there on the private market. China is "probably the only region that we're modeling a year-over-year increase in 2023" for Paxlovid, Conover said.

☆ 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.

But COVID-19 vaccine sales exceeded diminished expectations and demand for cancer drug Darzalex helped drive the fourth-quarter profit beat. The company reported $689 million in quarterly COVID-19 vaccine sales from outside the United States. J&J said it expects U.S. sales of Stelara to be flat to lower in 2023 due to competition from less expensive biosimilars in certain regions. It forecast adjusted 2023 earnings of $10.45 to $10.65 per share, above analysts' estimates of $10.35. Excluding items, J&J earned $2.35 per share for the quarter, topping analysts' estimates by 12 cents, according to IBES data from Refinitiv.

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☆ J&J forecasts 2023 profit above expectations on pharma strength
▼ + stars: | 2023-01-24 | by ( ) www.reuters.com time to read: +2 min

Shares of the drugmaker, however, fell 1% to $166.12 in premarket trading as fourth-quarter sales missed analysts' estimates due to lower demand for its medical devices. J&J expects to earn between $10.45 and $10.65 per share on an adjusted basis for 2023, above analysts' estimates of $10.35 per share profit at the midpoint. The higher 2023 profit forecast also reflects better-than-expected cost controls by J&J, Edward Jones analyst John Boylan said. Darzalex sales were $2.08 billion, while analysts were expecting $2.02 billion, according to Refinitiv. Excluding items, J&J earned $2.35 per share, above analysts' average estimates of $2.23 per share, according to IBES data from Refinitiv.

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☆ J&J forecasts strong 2023 profit on strength in pharma unit
▼ + stars: | 2023-01-24 | by ( ) www.reuters.com time to read: 1 min

Jan 24 (Reuters) - Johnson & Johnson (JNJ.N) on Tuesday forecast annual profit above Wall Street estimates as it bets on stronger demand for its pharmaceuticals products and a recovery in its medical devices business. J&J said it was expecting to earn between $10.45 and $10.65 per share on an adjusted basis for 2023, above analysts' estimates of $10.35 per share profit at midpoint. The healthcare conglomerate also beat estimates for fourth-quarter profit on Tuesday as increased sales of pharmaceutical products helped it weather a hit from a stronger dollarExcluding items, J&J earned $2.35 per share, above analysts' average estimates of $2.23 per share, according to IBES data from Refinitiv. Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

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☆ EMA seeks to issue guidance on liver damage from Novartis' gene therapy
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +1 min

Jan 13 (Reuters) - The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's (NOVN.S) Zolgensma, calling on them to monitor patients for any liver injury after treatment. The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August. Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness. The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks. In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

☆ Nearly 16 million Americans sign up for 2023 Obamacare plans
▼ + stars: | 2023-01-11 | by ( ) www.reuters.com time to read: +1 min

[1/2] U.S. President-elect Joe Biden adjusts his face mask after during a news conference, where he discussed health care and the Affordable Care Act (Obamacare, at the theater serving as his transition headquarters in Wilmington, Delaware, U.S., November 10, 2020. REUTERS/Jonathan ErnstJan 11 (Reuters) - Nearly 16 million Americans have so far signed up for health insurance through the Affordable Care Act's marketplace, a 13% jump from a year earlier, according to the U.S. Department of Health and Human Services (HHS) on Wednesday. Enrollment for 2023 healthcare plans under the Affordable Care Act, also known as Obamacare, is open between Nov. 1 and Jan. 15. About 3.1 million people who have signed up for the plans are new enrollees, HHS said. Obamacare helps low and middle-income Americans who do not have access to affordable health insurance coverage through an employer.

☆ Eisai, Biogen's Alzheimer's drug price should not dent demand, analysts say
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +2 min

Jan 9 (Reuters) - The $26,500-per-year price tag for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said. The U.S. health regulator on Friday granted accelerated approval to the drug, Leqembi, and the decision was hailed by patient groups. However, the price tag is lower than that of Eisai and Biogen's first Alzheimer's disease drug, Aduhelm, which was initially priced at $56,000 annually before the drugmakers halved the price amid controversy over its approval. Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full approval by the U.S. Food and Drug Administration. Some analysts expect broader coverage by Medicare if the drug is granted full approval.

☆ Eisai, Biogen's new Alzheimer's drug should be priced below Aduhelm - report
▼ + stars: | 2022-12-23 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Issei KatoDec 23 (Reuters) - An influential drug pricing research group said Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's disease treatment lecanemab should be priced lower than the drug Aduhelm that was developed by the companies. Biogen halved the price of its first Alzheimer's drug Aduhelm last year to $28,200 for a person with average weight, amid tepid sales and reimbursement hurdles. Treatment with lecanemab for patients with Alzheimer's appears to be "promising but inconclusive," ICER said. Eisai and Biogen did not immediately respond to requests for comment on the ICER report. Shares of Eisai fell on Friday after a report of a third death in a trial of lecanemab.

☆ BioNTech ships COVID shots to China for use by Germans
▼ + stars: | 2022-12-22 | by ( ) www.reuters.com time to read: +3 min

BioNTech said it is working with Shanghai Fosun Pharmaceutical (600196.SS) to deliver the shots to greater China, with availability expected in Beijing, Shanghai, Guangzhou, Shenyang and Chengdu. China would need to approve expanding access beyond the about 20,000 German nationals, the source said on Wednesday. "Most of Chinese here got the BioNTech vaccine, the vaccine that was first available. SinoVac vaccine was not available in Europe," a first-generation Chinese expatriate who has lived in Europe for more than a decade told Reuters. The expatriate, who asked to remain anonymous to protect their family in China, said that the government there might only make BioNTech shots available to Chinese nationals if it came to the worst-case scenario.

Dec 21 (Reuters) - China may be struggling to keep a tally of COVID-19 infections as the country experiences a big spike in cases, a senior World Health Organization official said on Wednesday, amid concerns about a lack of data from the country. "In China, what's been reported is relatively low numbers of cases in ICUs, but anecdotally ICUs are filling up," WHO's emergencies director Mike Ryan said. "I wouldn't like to say that China is actively not telling us what's going on. REUTERS/Denis BalibouseThe WHO said it was ready to work with China to improve the way the country collects data around critical factors such as hospitalisation and death. China has nine domestically developed COVID-19 vaccines approved for use, more than any other country, but they have not been updated to target the highly infectious Omicron variant.

☆ Madrigal NASH drug meets goals in much-awaited trial, shares surge
▼ + stars: | 2022-12-19 | by ( ) www.reuters.com time to read: +1 min

Dec 19 (Reuters) - Madrigal Pharmaceuticals' (MDGL.O) experimental drug for fatty liver disease met both of the main goals in a highly anticipated late-stage study, it said on Monday, sending the company's shares soaring over 200%. The positive data sets the stage for the drug, resmetirom, to become the first approved treatment for NASH, or nonalcoholic steatohepatitis, a disease that affects about 5% of adults in the United States. Data from the trial shows a lower 80 milligram dose helped 26% of patients reach NASH resolution, compared to 30% for a higher 100 milligram dose, and 10% for placebo. NASH is a form of nonalcoholic fatty liver disease, characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure. The company plans to file a marketing application seeking accelerated approval for the drug in the first half of 2023.

☆ U.S. FDA advisers to weigh on updating initial COVID vaccine doses
▼ + stars: | 2022-12-16 | by ( ) www.reuters.com time to read: +1 min

Dec 16 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants. While updated booster doses from Pfizer (PFE.N) and Moderna (MRNA.O) are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread. The independent advisers, who are scheduled to meet on Jan. 26, are also expected to weigh in on whether the timing or composition of booster doses need to be adjusted. In June, advisers to the FDA had recommended a change in the composition of COVID-19 booster shots before fall to combat more recently circulating variants of the coronavirus. Reporting by Bhanvi Satija and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.

Amgen gains several approved drugs through the deal, a bulwark against rising competition for its blockbuster arthritis drug, Enbrel, from newer treatments. Sales of Amgen's Enbrel tumbled 14% in the latest reported quarter to $1.1 billion, extending a run of downbeat performances. The Horizon bid follows Amgen's $3.7 billion deal in August for rare blood vessel inflammation treatment maker ChemoCentryx Inc . The offer values Horizon at $27.8 billion on a fully diluted basis, according to the company, which includes ordinary shares to be vested. Based on Reuters calculations, it values Horizon at about $26 billion and gives Horizon a $28.3 billion valuation, including debt.

☆ Amgen to buy Horizon Therapeutics for $26.40 billion
▼ + stars: | 2022-12-12 | by ( ) www.reuters.com time to read: +1 min

Dec 12 (Reuters) - Amgen Inc (AMGN.O) will buy rare disease drugmaker Horizon Therapeutics Plc (HZNP.O) for $26.40 billion, it said on Monday, in its biggest deal ever that gives the biotech company access to blockbuster thyroid eye disease treatment Tepezza. The offer values Horizon at $27.8 billion on a fully diluted basis, according to the company, which includes ordinary shares to be vested. Based on Reuters calculations, it values Horizon at $26.40 billion. The offer values Horizon at $28.3 billion, including debt. The Wall Street Journal on Sunday reported that Amgen was close to acquiring Horizon after the other bidders pulled out of the race.

☆ Drop in COVID alertness could create deadly new variant - WHO
▼ + stars: | 2022-12-02 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Dec 2 (Reuters) - Lapses in strategies to tackle COVID-19 this year continue to create the perfect conditions for a deadly new variant to emerge, as parts of China witness a rise in infections, the head of the World Health Organization said on Friday. BAY ISMOYO/Pool via REUTERS 1 2"Gaps in testing ... and vaccination are continuing to create the perfect conditions for a new variant of concern to emerge that could cause significant mortality," Tedros said. COVID-19 infections are at record highs in China and have started to rise in parts of Britain after months of decline. Further easing of COVID-19 testing requirements and quarantine rules in some Chinese cities was met with a mix of relief and worry on Friday, as hundreds of millions await an expected shift in national virus policies after widespread social unrest. The WHO urged governments globally to focus on reaching those at risk, such as people over the age of 60 and those with underlying conditions, for vaccination.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ Amazon launches virtual healthcare clinic in U.S. for common ailments
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

Nov 15 (Reuters) - Amazon.com Inc (AMZN.O) on Tuesday launched Amazon clinic, a virtual platform where users can connect with healthcare providers to help treat common ailments like allergies and skin conditions. Amazon has for years sought to expand its presence in healthcare. It bought online pharmacy PillPack in 2018, underpinning a prescription delivery and price-comparison site it later launched as Amazon Pharmacy, which lets users buy over-the-counter drugs via Prime memberships. Amazon saidits new service would operate in 32 states, where customers who seek treatment, will be connected to healthcare providers. read moreThe company is also waiting to close its $3.49 billion deal to buy One Medical, as it seeks to expand its virtual healthcare presence and add brick-and-mortar doctors' offices for the first time.

☆ Biogen hires former Sanofi head Viehbacher as CEO
▼ + stars: | 2022-11-10 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

The appointment of Viehbacher, who founded private equity firm Gurnet Point Capital after being ousted from French drugmaker Sanofi (SASY.PA) in 2014, concludes a months-long search for a successor to Michel Vounatsos. "The selection of a new CEO has been front-of-mind for Biogen investors since Mr. Vounatsos' announced departure," said Wedbush analyst Laura Chico. Investors and analysts are now pinning their hopes on the second Alzheimer's drug Biogen is developing with Japan's Eisai Co Ltd (4523.T) after it slowed the progress of the memory-robbing disease by 27% in a trial. Viehbacher served as chief executive of Sanofi for six years and was instrumental in the company's $20 billion deal for Genzyme in 2011. Viehbacher will step into his role on Nov. 14, Biogen said.

☆ Moderna cuts COVID vaccine sales forecast on supply woes, shares tumble
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - Moderna Inc (MRNA.O) cut its annual sales forecast for its COVID-19 vaccine on Thursday, citing short-term supply constraints that would push some deliveries out to next year, sending its shares down nearly 16% before the bell. It now expects vaccine sales of $18 billion and $19 billion this year compared to a prior forecast of $21 billion. Some U.S. pharmacies in September had reported that government supply of Moderna's updated shot remains limited, causing appointments for the product to vary across the country. Moderna's forecast cut comes just two days after rival Pfizer Inc's (PFE.N) quarterly sales of its COVID-19 vaccine exceeded market expectations and the drugmaker raised the full-year sales forecast for its shots. The vaccine maker reported sales of $3.36 billion in the third quarter, missing Wall Street estimates of $3.53 billion.

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for 2022 sales of its COVID-19 vaccine by $2 billion to $34 billion, and said new deals and drugs in development should help replace future declining vaccine sales and lost revenue from patent expirations. Sales of the Pfizer/BioNTech COVID vaccine are down from pandemic highs as many countries have neared the end of their primary vaccination campaigns. Third-quarter sales of the COVID vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion. However, $7.51 billion in sales of Paxlovid, the company's COVID-19 antiviral treatment, fell short of estimates of $7.66 billion. Pfizer reported adjusted earnings of $1.78 per share in the third quarter, beating analysts' estimates by 39 cents.

☆ Pfizer boosts COVID vaccine sales forecast by $2 bln
▼ + stars: | 2022-11-01 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations. The U.S. drugmaker's shares rose 2.4% to $447.67 in morning trading as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. The upbeat earnings also sent shares of rival COVID-19 vaccine makers higher. Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years. Third-quarter sales of the COVID-19 vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion.

☆ Pfizer boosts COVID vaccine sales forecast by $2 bln to $34 bln
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations. The U.S. drugmaker's shares rose 4.3% to $48.55 in premarket trading as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years. Third-quarter sales of the COVID-19 vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion, according to five analysts polled by Refinitiv. However, $7.51 billion in sales of the company's COVID-19 pill Paxlovid missed estimates of $7.66 billion.

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