Tag: Pfizer

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

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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

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

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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

Breast cancer treatment gets cheaper in India 

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

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Breast cancer treatment in India just became cheaper. In an important development this week, Pfizer’s drug branded as Palbace in India went off patent on January 10th midnight, allowing generic competition to enter the market. The generic name of the drug is Palbociclib and is used in the advanced treatment of metastatic breast cancer. The treatment will now cost under Rs 5000, 1/10th of the earlier cost.

Remember, today breast cancer is ranked as the number one cancer among Indian females accounting for 14 percent of cancers in Indian women with more than 50 percent of Indian women suffering from Stage 3 and 4 of breast cancer. Among the total patients approximately 50 percent have hormone receptor positive, a major sub type. Though hormone receptor has shown better survival they may present or progress to metastatic disease.

Also Read: Turning cancer cells into anti-cancer agents: Study

 With branded generic competition entering, prices of Palbociclib have fallen by over 90 percent overnight for all three strengths -75mg, 100 mg and 125mg.

To illustrate this better, the 125 mg strength of 21 tablets,  the standard monthly therapy cost, by Pfizer, until now cost Rs 95000. Now, the same 21 tablets will cost a fraction. For example, pharma company BDR Pharma’s 21 tablets in the 125 mg strength is available at Rs 4464 which is 95 percent cheaper and Sun Pharma’s at Rs 6199 which is 93 percent cheaper than the earlier existing treatment.

 Lower prices by reputed firms is a huge relief for patients point out experts as it will increase both accessibility and affordability of the drug. Cos such as Sun pharma have introduced the drug with a Patient Assistance program which is expected to further improve compliance. Going forward, more competition from branded generic is likely to come in with at least 10-15 cos slated to launch. This will drive prices even lower which would be a further win for patients.

Also Read: Sun Pharma arm launches novel breast cancer drug in India

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

Glenmark reaches settlement agreement with Pfizer for kidney cancer drug

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

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[wealthdesk shortname=”Glenmark” isinid=”INE935A01035″ bseid=”532296″ nseid=”GLENMARK” sector=”Pharmaceuticals” exchange=”nse”]

Glenmark Pharma and its US subsidiary – Glenmark Pharmaceuticals Inc., USA have reached a settlement agreement with Pfizer Inc. and its entities – PF Prism CV and PF Prism IMB BV for the Axitinib tablets, 1 mg and 5 mg.

The tablets are generic versions of Pfizer’s Inlyta tablets and are used in the treatment of advanced renal cell carcinoma, a type of cancer that begins in the cells of the kidneys. It is used on patients who have not been treated successfully with another medication.

Glenmark had received tentative approval from the USFDA for their generic Axitinib tablets, 1 mg and 5 mg in November 2020.

For the 12-month period that ended in September 2022, Pfizer’s 1 mg and 5 mg Inlyta tablets had achieved annual sales of close to $644.5 million, according to IQVIA data.

Glenmark’s current portfolio includes 177 products that are authorised for distribution in the US market place and 47 Advanced New Drug Applications (ANDAs) are pending approval with the drug regulator.

Earlier this month, Glenmark had launched the Fingolimod capsules in the US market. The drug is used in the treatment of multiple sclerosis in patients aged 10 and above.

In its recent investor day, the company’s management guided for double-digit revenue growth over the next four years. Among other targets that the company set for financial year 2026 include zero net debt and enhancing dividend payout and buybacks for investors.

Over the next four financial years, Glenmark aspires to have 2/3rd of its revenue from branded products and markets. It also wants to have a commercial launch of at least one innovative asset either on its own or via partners.

Shares of Glenmark have opened 0.9 percent higher at Rs 415.25.

Also Read: Glenmark shares drop after USFDA places Baddi unit under import alert

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 pays $116 million for app that detects COVID-19 infections from the sound of cough

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

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Pharma giant Pfizer has shelled out nearly USD 120 million to acquire a small Australian company that has developed a smartphone app which claims to accurately diagnose COVID-19 by analysing the sound of a cough.

ResApp, the Australian digital healthcare company, has been working on developing an algorithm to diagnose respiratory illnesses by studying the sound of a patient’s cough for about a decade.

The algorithm of ResApp was originally trained to identify pneumonia in patients, but by 2019, researchers had demonstrated that the technology could successfully differentiate between asthma, bronchiolitis, and croup.

Also read: COVID-19 virus may turn against itself by new drug, claims US study

ResApp team rapidly changed course to add COVID-19 diagnoses into their cough-recognition algorithm when the pandemic hit in 2020. The initial data from a pilot trial of the algorithm in 2022 showed remarkably successful results in detecting COVID-19 in patients, as per a Techtimes report.

The trial results demonstrated that the system could accurately identify 92 percent of COVID positive cases just by listening to the sound of coughing. It also showed an 80 percent specificity rate, which means that only 2 two out of every 10 patients screened had false positive results.

Pfizer started looking for an opportunity to get the technology after ResApp made these findings public.

Also read: Blood test could predict people at risk of long COVID, says Lancet study

The pharma giant approached with an initial offer of about USD 65 million for the technology. However, currently a deal has been reached for Pfizer to acquire ResApp for a staggering USD 116 million, as per a formal purchase announcement.

Pfizer representative said in a statement that the early results of the technology were encouraging, and that the agreement increases the Pfizer’s presence in the field of digital health.

The ResApp team hopes that Pfizer’s acquisition will enable the technology to develop and become extensively used even in the remote regions of the world to help people.

Also read: Moodier, more prone to stress — COVID-19 pandemic linked to altered personality in young adults, find US study

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 declares interim dividend of Rs 30 per share after sale of Upjohn business

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

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The US-based pharma major Pfizer Ltd on Tuesday said it has declared an interim special dividend of Rs 30 per equity share for the financial year ending March 31, 2023.

In a regulatory filing, the company said, “The Board of Directors at its meeting held today, i.e., September 6, 2022, has declared an Interim (Special) Dividend of Rs. 30/- per equity share of Rs. 10/- each (300%) for the financial year ending March 31, 2023, in view of the gain on account of sale of Upjohn Business to Mylan Pharmaceuticals Private Ltd.”

This is the first interim dividend the company has announced for this fiscal. September 20, 2022, has been the record date for the purpose of payment of dividends.

Also Read: Reliance Industries expands new energy presence with SenseHawk deal

Back in 2021, Pfizer had entered into an agreement with Mylan Pharmaceuticals to sell its Upjohn business for Rs 180.48 crore.

“The Upjohn business comprises six brands which include Lyrica, Viagra, Celebrex, Amlogard, Daxid and Dilantin. These along with related business assets and liabilities will transition to Mylan,” the filing said.

The rationale for the transaction is that Pfizer Inc, USA, on July 29, 2019, announced that it had entered into a definitive agreement to combine its Upjohn business — which consists of off-patented branded and generic established medicines — with Mylan N.V., thereby creating a new global pharmaceutical company, Viatris Inc.

Also Read: A Kolkata-based lender’s valuation is catching attention on Dalal Street — here’s why

Under the global transaction, six brands currently marketed by Pfizer Ltd in India, viz., Lyrica, Viagra, Celebrex, Amlogard, Daxid and Dilantin, will transition to Mylan Pharmaceuticals.

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 COVID pill shows no benefit in younger adults, says Israeli study

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

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Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalisation and death for high-risk seniors, according to a large study published Wednesday.

The results from a 1,09,000-patient Israeli study are likely to renew questions about the US government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to its at-home convenience. The

The researchers found that Paxlovid reduced hospitalisations among people 65 and older by roughly 75 percent when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the US and other nations.

But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.

The study has limitations due to its design, which compiled data from a large Israeli health system rather than enrolling patients in a randomised study with a control group — the gold-standard for medical research.

The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe COVID-19 complications. The Centers for Disease Control and Prevention

“Paxlovid will remain important for people at the highest risk of severe COVID-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician, who was not involved in the study. “But for the vast majority of Americans who are now eligible, this really doesn’t have a lot of benefit.”

A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.

Also Read: Coronavirus in India: Over 10,000 new COVID-19 cases recorded, 36 deaths reported

The US Food and Drug Administration

At the time of the FDA decision there were no options for treating COVID-19 at home, and Paxlovid was considered critical to curbing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also far stronger than a competing pill from Merck.

The FDA made its decision based on a Pfizer study in high-risk patients who hadn’t been vaccinated or treated for prior COVID-19 infection. “Those people do exist but they’re relatively rare because most people now have either gotten vaccinated or they’ve gotten infected,” Boulware said.

Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — failed to show a significant benefit. Those results have not yet been published in a medical journal.

More than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized, according to federal records.

Also Read: Delhi sees rise in COVID-19 cases, positivity rate at 20% but only 10% hospitalised took booster dose

A White House spokesman on Wednesday pointed to several recent papers suggesting Paxlovid helps reduce hospitalizations among people 50 and older. The studies have not been published in peer-reviewed journals.

“Risk for severe outcomes from COVID is along a gradient, and the growing body of evidence is showing that individuals between the ages of 50 and 64 can also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.

Administration officials have been working for months to increase use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, US officials

The White House recently signaled that it may soon stop purchasing COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. Under that scenario, insurers could set new criteria for when they would pay for patients to receive Paxlovid.

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

Study says COVID mRNA vaccines safe during pregnancy — 10 key points

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

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A new Lancet study has found COVID-19 mRNA vaccines to be safe to be administered during pregnancy. It also revealed that there were “lower rates of significant adverse events following immunisation in pregnant people than non-pregnant vaccine recipients for both mRNA vaccines used in Canada, after dose one and dose two.”

The study also supported the importance of high vaccine coverage for the protection of pregnant persons and infants. The study, published in The Lancet Infectious Diseases, was conducted between December 2020 and November 2021 among participants across seven Canadian provinces.

It included samples of pregnant, vaccinated women aged 15-49 years. These were compared with samples of non-pregnant vaccinated women and pregnant unvaccinated falling in a similar age group. “For statistical modelling, the analysis was restricted to those who received any mRNA vaccines BNT162b2 (Pfizer) and mRNA-1273 (Moderna)”.

“COVID-19 mRNA vaccines have a good safety profile in pregnancy,” it said in conclusion.

In this study, researchers also focused on the side effects in a group of vaccinated pregnant women simultaneously as both an unvaccinated pregnant group and a vaccinated non-pregnant group. Rates of significant adverse events following immunisation were highest after the second dose for Moderna recipients. However, it said, “both mRNA vaccines are highly immunogenic and effective in pregnancy.”

Here are some key takeaways from the study

Overall, 226 (4·0 percent) of 5,597 mRNA-vaccinated pregnant females reported a significant health event within seven days after dose one of an mRNA vaccine, and 227 (7·3 percent) of 3,108 after dose two.

1. The health event rates were similar after dose one for both mRNA vaccines — 137 of 3,414 for Pfizer BioNTech and 89 of 2183 for Moderna — but higher for Moderna than Pfizer after dose two.
2. The most common significant health events after the second dose of Moderna in pregnant women are feeling unwell or malaise or myalgia (139 of 1,216), headache or migraine (103 of 1,216), and respiratory tract infection (68 of 1,216).
3. Among pregnant and vaccinated participants who reported significant health events, most of them recognised their symptoms within 24 hours following vaccination — 57·5 percent of 226 after dose one and 82·4 percent of 227 after dose two of an mRNA vaccine. The majority — 54·9 percent of 226 after dose one and 74·0 percent of 227 —  resolved within three days.
4. In comparison, 3·2 percent of 339 pregnant unvaccinated (control group) participants reported similar events in the seven days before survey completion. Of these, 18·2 percent reported their symptoms as resolved at least 24 hours before the control survey and 81·8 percent reported their events as ongoing for at least six days.
5. The reported serious health events were rare — reported among eight (0·4 percent) of 1,892 and 11 (0·9 percent) of 1216 across various pregnant groups. This occurred at similar rates in vaccinated pregnant individuals and unvaccinated controls and after doses one and two for all vaccine types.
6. Miscarriage or stillbirth was the most frequently reported adverse pregnancy outcome, and it was reported at similar rates between control (2·1 percent of 339) and vaccinated groups within seven days after dose one of any mRNA vaccine. Almost all pregnancy losses occurred during the first trimester.
7. Other adverse pregnancy outcomes such as vaginal bleeding, abnormal fetal heart rate, and reduced fetal movement were rarely reported within seven days following any mRNA vaccination.
8. The first dose of any mRNA vaccine and either dose of Pfizer were not associated with an increased risk of significant health events. Similarly, the researchers found “no significant association between vaccination status and serious health events in pregnant people”.
9. The increase in significant health events after dose two of any mRNA vaccine was no longer observed when researchers restricted their outcome variable to events requiring medical consultation. “When restricted to events resulting in medical consultation, there was no difference between groups in any of the analyses.”
10. Pregnant people in this study reported high rates of injection site pain (92 percent after dose two), fatigue (72 percent), headache (55 percent), myalgia (54 percent) and fever or chills (35–37 percent), with higher rates of adverse events after dose two than after dose one.

Conclusion

“…We found that significant health events — new or worsening health events following vaccination sufficient to cause work or school absenteeism, medical consultation, or prevent daily activities — were lower in pregnant people than in age-matched non-pregnant vaccine recipients,” the study said.

Researchers said the data could be used to appropriately inform pregnant people regarding the “reactogenicity of COVID-19 vaccines” during pregnancy. The finding should also be considered alongside effectiveness and immunogenicity data to make appropriate recommendations about the “best use of COVID-19 vaccines in pregnancy”.

What are COVID-19 mRNA vaccines?

The Pfizer-BioNTech and Moderna COVID-19 vaccines are messenger RNA (mRNA) vaccines. According to the CDC, many vaccines put a weakened or inactivated germ into our bodies to trigger an immune response.

But this is not the case with mRNA vaccines. These vaccines use “mRNA created in a laboratory to teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies”.

This immune response, which produces antibodies, is what helps protect people from getting sick from that germ in the future.

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