Tag: Pfizer

Tornado damages Pfizer plant in North Carolina, US

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drugmaker Pfizer Inc on Wednesday said its North Carolina plant in Rocky Mount, suffered heavy damages from a tornado. The plant is one of the largest sterile injectable product facilities across the globe.

A spokesperson from Pfizer in an emailed statement said the Rocky Mount facility was damaged and the company was assessing the situation to better understand the impact on production, news agency Reuters reported.

The employees of the company present at the site were able to evacuate and were safe, the drugmaker’s statement added.

The Rocky Mount facility produces around 30 percent of all sterile injectables used in US hospitals and also focuses on manufacturing a variety of products such as neuromuscular blockers, anti-infectives, as well as syringes and vials.

The facility has around 4,500 professionals on board.

With inputs from Reuters

Also Read: WHO issues warning against cough, cold remedies containing Pholcodine

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

FDA votes for COVID vaccines targeting XBB variants, Pfizer aims for July production

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer Inc. has said that it can produce COVID-19 vaccines that target the XBB.1.5 strain by the end of July, provided government regulators recommend it. The pharmaceutical giant, in collaboration with BioNTech SE, also stated that the development of a vaccine for the XBB.1.16 strain would take a bit longer, with an estimated delivery time of August.

These announcements were made by Kena Swanson, Pfizer’s vice president for viral vaccines, during a meeting of the US Food and Drug Administration’s vaccine advisers on Thursday.

The committee also unanimously voted for monovalent COVID shots in the fall and winter targeting the XBB variants, which are now the dominant strains of the SARS-CoV-2 virus in the world.

Why do we need updated vaccines?

Initially designed to combat the original strain of COVID-19 that originated in Wuhan, China, vaccines have undergone adaptations to address emerging variants.

Updated vaccines are necessary to address the ongoing evolution of the SARS-CoV-2 virus and its emerging variants. As the virus mutates over time, new strains with different characteristics can emerge, potentially rendering existing vaccines less effective.

ALSO READ | New study reveals overactive inflammation as potential cause of long COVID

By developing updated vaccines that specifically target these new strains, we can enhance protection against the latest variants, reduce the likelihood of breakthrough infections and maintain the effectiveness of vaccination campaigns in mitigating the spread of the virus and preventing severe illness.

Pfizer’s presentation at the FDA meeting indicated that targeting a single strain of XBB, a highly contagious version of the omicron variant, would be the most effective approach based on the latest data.

In line with these findings, a panel from the World Health Organization recommended in May that vaccine manufacturers focus on developing shots for the XBB.1 strains. Moderna Inc. also expressed its ability to supply a new vaccine later this year, supporting the WHO’s recommendation.

ALSO READ | 3 infections, 1 test | NIV’s test kit for Influenza A, Influenza B, COVID-19 up for grabs

Novavax, a biotechnology company, shared its plans to have a vaccine targeting the XBB.1.5 strain ready for distribution in the fall. However, any potential delay in production may occur if the FDA advises a different formulation

For instance, vaccines directed at the XBB.1.16 strain would likely require an additional eight weeks of development, as explained by Filip Dubovsky, Novavax’s president of research and development, during the meeting.

With agency inputs.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer Q4 net up 3% at Rs 130 crore

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug firm Pfizer on Monday said its net profit increased by 3 percent to Rs 130 crore for the fourth quarter ended March 31, 2023. The company reported a net profit of Rs 126 crore in the January-March quarter of last year.

Total income increased to Rs 604 crore in the fourth quarter as compared with Rs 567 crore in the year-ago period, Pfizer Ltd said in a regulatory filing. For the year ended March 31, 2023, the company reported a net profit of Rs 624 crore as against Rs 613 crore in FY22.

Total income declined to Rs 2,526 crore last fiscal as compared with Rs 2,674 crore in the 2021-22 fiscal.

Also Read: HAL Q4: Strong results, Margins jump 430 bps, Order book in excess of Rs 81,700 crore

The company said its board recommended a final dividend of Rs 35 per share of Rs 10 each (350 percent) and a special dividend of Rs 5 per share of Rs 10 each (50 percent) in view of the gain on the sale of business undertaking at Thane, aggregating to a total dividend of Rs 40 per share of Rs 10 each for the financial year ended March 31, 2023.

Shares of the company ended 0.69 percent up at Rs 3,816.75 apiece on the BSE.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer’s Q1 results beat estimates despite sharp COVID-19 vaccine sales drop

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer on Tuesday, May 2, announced its first quarter results, which exceeded Wall Street’s expectations, despite a sharp decline in sales of its flagship COVID-19 vaccine. In the first three months of 2021, revenue from Pfizer’s Comirnaty vaccine plummeted by 77 percent, generating only $3 billion in sales, compared to over $13 billion in the same period last year.

The drugmaker saw a significant decline in net income in the first quarter, with a 30 percent decrease amounting to $5.54 billion, with adjusted results totalling $1.23 per share. The company’s total revenue also decreased by 29 percent to $18.3 billion.

Nevertheless, it beat the Street expectations.

According to FactSet, a financial data and software company, analysts predicted that Pfizer would report earnings of 98 cents per share on $16.61 billion in sales.

Many industry experts anticipated the decline in sales of Pfizer, as the company transitions from supplying governments through large contracts to selling the vaccine in the commercial market this year. As a result of this shift, Pfizer has forecast a 64 percent drop in Comirnaty sales this year and a 58 percent decline in revenue from its leading COVID-19 treatment, Paxlovid.

In the first quarter, sales for Paxlovid surpassed $4 billion, primarily due to the timing of a final delivery for Pfizer’s US government contract.

Also read: Ambuja Cements Q4 profit rises marginally to Rs 502 crore; co announces final dividend

Pfizer expects commercial sales for both to kick in later this year, after leftover government inventory is absorbed.

Over the past several quarters, both the vaccine and treatment for COVID-19 have generated substantial revenue for Pfizer. However, in addition to these products, Pfizer also produces cancer treatments and other vaccines.

In the first quarter, revenue for Pfizer’s Prevnar vaccine, which helps prevent pneumonia and related bacterial diseases, grew by 4 percent to reach $1.6 billion.

Also read: UCO Bank Q4 results: Net profit zooms 86% to Rs 581 crore as bad loans decline

Pfizer reaffirmed its estimate for full-year earnings to be between $3.25-3.45 per share.

In January, when Pfizer first released this forecast, it was initially below what Wall Street had anticipated.

Also read: Titan Q4 Result Preview: Operating margin, June quarter outlook key to track

As per FactSet, analysts have revised their earnings estimate for Pfizer to $3.39 per share.

As a result, shares of Pfizer, which is headquartered in New York, started to rise in early-morning trading.

With inputs from agency

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Arbutus sues Pfizer, BioNTech over COVID vaccine patent, demands reasonable royalty

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Arbutus Biopharma on Tuesday sued U.S. drugmaker Pfizer Inc and its German partner BioNTech SE in a New Jersey district court, claiming their mRNA COVID-19 vaccines infringe five of Arbutus’ patents.

Arbutus, along with its licensee Genevant Sciences, is seeking damages, including reasonable royalties, over the use of lipid nanoparticle (LNP) delivery technology in Pfizer/BioNTech vaccines to carry and transfer genetic material into the body.

The lawsuit by Arbutus and Genevant says Pfizer/BioNTech engaged in licensing discussions for the technology but they did not “result in a settlement”.

Genevant is a joint venture between Arbutus and Roivant Sciences Ltd.

Arbutus Biopharma had also sued Moderna Inc in the Delaware federal court last year, claiming the latter’s mRNA COVID-19 vaccine also infringes its patents.

In its lawsuit against Moderna, Arbutus had said it was not looking to block the drugmaker from producing or distributing the vaccines but was seeking monetary damages including a reasonable royalty.

“Pfizer and BioNTech are aware that Arbutus Biopharma and Genevant Sciences have filed an action for infringement with respect to certain U.S. Patents,” BioNTech told Reuters, and added that the companies would not comment on their legal strategy.

Pfizer had said earlier in the day that the company “will vigorously defend against the allegations of the lawsuit.”

Arbutus declined to comment beyond the press release.

Moderna had sued Pfizer and BioNTech in August 2022 for allegedly infringing three patents related to their multibillion-dollar mRNA COVID-19 vaccines.

Pfizer and BioNtech are facing another patent infringement lawsuit related to the vaccines brought by Alnylam Pharmaceuticals Inc in March 2022.

Arbutus fell 2.6 percent to $2.98 on Tuesday, while Pfizer was down 1.2 percent and U.S.-listed shares of BioNtech dropped almost 3 percent.

Also read: WHO revises COVID-19 vaccine recommendations for Omicron-era

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer shares decline for the 13th consecutive session, fall to a 52-week low

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of pharmaceuticals giant Pfizer dropped nearly 2 percent in trade to hit a 52-week low on Tuesday. The stock has hit a 52-week low in each trading session since March 14 extending its losing streak to 13th day on the trot.

Since February 20, shares of Pfizer have gained only twice.

Pfizer has lost nearly 8 percent in the last one month even as the pharma major’s parent company, recently announced plans to purchase Seagen in a whopping $43 billion deal to expand its involvement in cancer treatment. In the past three months the stock has declined nearly 21 percent.

The company’s parent on March 13 stated that it has entered into a deal to acquire Seagen at a cost of $229 per share.

Seagen Inc, headquartered in Bothell, Washington, is a biotech company that focuses on drug development.

Its primary products utilise monoclonal antibodies that attach to the surface of cancer cells and transport a cancer-fighting agent, while preserving nearby healthy tissue.

Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise, the company had stated.

The company last month also completed the sale of its Thane business undertaking to Vidhi Research and Development LLP.

On September 23, 2015, Pfizer announced the sale of the company’s business undertaking located at Thane Belapur Road, in Navi Mumbai, for a lump sum consideration of Rs 178 crore.

Shares of Pfizer are trading 0.6 percent lower at Rs 3,513.05

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer to acquire Seagen for $43 billion in a bid to strengthen cancer treatment

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer, the pharmaceutical giant, has announced its plan to purchase Seagen for USD 43 billion to expand its involvement in cancer treatment. According to the company’s statement on Monday, Pfizer will acquire Seagen at a cost of USD 229 per share.

“Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement.

Seagen Inc., headquartered in Bothell, Washington, is a biotech company that focuses on drug development. Its primary products utilise monoclonal antibodies that attach to the surface of cancer cells and transport a cancer-fighting agent, while preserving nearby healthy tissue.

Also read: Risks associated with H3N2 virus and flu vaccination in India | Explained

Monoclonal antibodies are lab-made proteins delivered mostly by IV at an infusion center, according to the Cleveland Clinic.

Seagen’s top seller, Adcetris, treats lymph system cancers. It brought in USD 839 million in sales last year, a 19 percent increase over the previous year.

Aside from Adcetris, Seagen also has a deal with Pfizer’s Array BioPharma to develop, make and sell the breast and colorectal cancer treatment Tukysa. It brought in USD 353 million in sales last year.

Seagen also saw sales grow 33 percent to USD 451 million last year for Padcev, which treats some cancers of the urinary tract, including the bladder. The drugmaker is developing and selling that treatment with Astellas Pharma Inc.

Seagen anticipates generating approximately USD 2.2 billion of revenue this year, representing 12 percent year-over-year growth, from its four in-line medicines, royalties and collaboration and license agreements.

Pfizer believes Seagen could contribute more than USD 10 billion in risk-adjusted revenues in 2030, with potential significant growth beyond 2030.

Seagen, which changed its name from Seattle Genetics in 2020, shaved its loss to USD 610 million last year. That’s down from USD 674 million in 2021. Total revenue grew about 25 percent last year to nearly USD 2 billion.

The company named former Novartis executive David Epstein CEO in November. Long-time CEO and co-founder Clay Siegall resigned last spring.

Also read: Karnataka reports India’s first H3N2 death — issues health advisory

Cancer treatments are one of Pfizer’s main businesses. That portfolio of drugs includes the breast cancer treatment Ibrance, which brought in nearly USD 1.3 billion in sales last year.

Pfizer recorded about USD 100 billion in total revenue last year and has been flush with cash thanks to sales of its COVID-19 vaccine and treatment, Comirnaty and Paxlovid.

CEO Albert Bourla said earlier this year that the company planned to use its “extraordinary firepower” to buy products that will deliver USD 25 billion in incremental revenue by 2030.

New York-based Pfizer Inc. has already spent USD 11.6 billion on migraine treatment developer Biohaven Pharmaceutical.

It also spent USD 5.4 billion on sickle cell disease treatment maker Global Blood Therapeutics and bought Arena Pharmaceuticals for another USD 6.7 billion.

Bourla said in January that Pfizer plans to launch 19 new products or new indications for existing products over the next year and a half.

The drugmaker needs more revenue sources in part because it faces the expiration of patents protecting drugs like Ibrance from cheaper competition in the coming years.

Both companies’ boards have unanimously approved the deal. The companies expect to complete the transaction in late 2023 or early 2024. It still needs approval from Seagen’s stockholders.

Also read: Odisha increases surveillance after 59 H3N2 influenza cases reported in 2 months

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer completes sale of Thane business undertaking to Vidhi Research for Rs 178 crore

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pharmaceutical major Pfizer Ltd. has completed the transfer of its Thane business undertaking to Vidhi Research and Development LLP. The company said that it has transferred land, plant, machinery, and all the workmen employed at the Thane undertaking to Vidhi Research effective close of business on February 24, 2023.

On September 23, 2015, Pfizer announced the sale of the company’s business undertaking located at Thane Belapur Road, KU Bazar Post, Navi Mumbai, for a lump sum consideration of Rs 178 crore.

The plant was commissioned in the 1960s and supplied drugs to both domestic and international markets.

The sale of the undertaking came months after Pfizer announced in July 2015 that it would close its over 50-year-old Thane plant from September 16, 2015, which had been lying idle since 2013.

A Pfizer spokesperson had said at that time that the decision to close the site was based on an assessment of its long-term viability and its ability to achieve the needed production.

Shares of Pfizer Ltd. are trading 0.23 percent lower at Rs 3,799.05.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

COVID-19: Pfizer bivalent vaccine linked to strokes in preliminary data

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer Inc.’s bivalent shot for Covid-19 has shown a potential link to stroke in people 65 and older, according to US health officials citing preliminary data from one of several vaccine safety databases.

The potential risk with Pfizer’s vaccine was not seen in other safety databases, nor was it seen with Moderna Inc.’s COVID vaccine, the officials said in a statement on the Food and Drug Administration’s website. The early finding still needs more investigation, and recommendations for the vaccine have not been changed, the statement said.

“When we find a signal we look for it in other parts of the system, which is what we’ve done (and will continue to do),” Kristen Nordlund, a spokesperson for the Centers for Disease Control and Prevention, said in an email.

Also read: Pfizer to offer low-cost medicines, vaccines to poor nations

The agencies said the possible link to stroke was seen in the CDC’s Vaccine Safety Datalink. Investigation of the signal raised a question of whether people 65 and older who received the Pfizer-BioNTech bivalent shot were more likely to have an ischemic stroke, a loss of blood flow in the brain, in the 21 days following vaccination compared with days 22-44 following vaccination, the agencies said in the statement.

“The totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk,” the statement said.

Pfizer’s bivalent booster is armed specifically to protect against two omicron variants, called BA4 and BA5. Messenger RNA Covid shots have been linked to pericarditis and myocarditis, inflammation of the heart and its surrounding tissue that’s usually mild.

Also read: COVID vaccine: These are most common side effects, according to CDC

Pfizer and its partner BioNTech Se “have been made aware of limited reports of ischemic stroke” in the CDC Vaccine Safety DataLink database in people 65 and older following vaccination after the companies’ bivalent shot, a spokesperson said. There is no data to conclude that Pfizer’s vaccine is causally associated with stroke, the spokesperson said.

Among 5,50,000 people 65 and older who had been vaccinated and received the Pfizer bivalent booster, 130 had strokes in the first three weeks after getting the shot, according to the CDC, and no deaths have been reported.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow