Tag: AstraZeneca

AstraZeneca begins worldwide withdrawal of COVID-19 vaccine

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

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AstraZeneca has initiated the worldwide withdrawal of its COVID-19 vaccine Vaxzevria due to a “surplus of available updated vaccines” which has led to a decline in its demand.

“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company told Telegraph. The vaccine is neither being manufactured nor supplied.

The report said that the firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7. The report said the vaccine cannot be used in the European Union after the company withdrew its “marketing authorisation”.

Media reports said that the company has admitted in court documents that the vaccine causes side-effects such as blood clots, low blood platelet counts and “in very rare cases, cause TTS or Thrombosis with Thrombocytopenia Syndrome”. The company is being sued by more than 50 alleged victims and relatives in a High Court case.

The drugmaker faces a £100 million lawsuit in the UK over claims that the Covid jab caused deaths and injuries to several people.

Without referring to the side effects, the company said, “we are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally. It added, “Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.”

In India, over 220 crore dosages of COVID-19 vaccines have been administered and a majority of those were Covishield.

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

AstraZeneca admits Covid vaccine could cause rare side effects in court filing

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

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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

AstraZeneca bets on new cancer treatments with $2 billion Fusion Pharma purchase

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

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AstraZeneca said on Tuesday it will buy clinical-stage biopharmaceutical company Fusion Pharmaceuticals Inc for about $2 billion in cash as the Anglo-Swedish drugmaker bets on next-generation cancer treatments.

The deal is AstraZeneca’s second this month after it agreed last week to buy Amolyt Pharma for $1.05 billion to shore up its rare disease portfolio. The drugmaker will pay $21 per Fusion share, a premium of more than 97% to the US-listed company’s closing price on Monday.

Fusion is developing “next-generation” radioconjugates (RCs) to treat cancer. RCs deliver a radioactive isotope directly to cancer cells through precise targeting using molecules and have emerged as a promising modality in cancer treatment over recent years, AstraZeneca said.

Fusion’s most advanced programme is the FPI-2265, which is currently in a mid-stage trial to treat patients with metastatic castration-resistant prostate cancer.

“Between 30 and 50% of patients with cancer today receive radiotherapy at some point during treatment, and the acquisition of Fusion furthers our ambition to transform this aspect of care with next-generation radioconjugates,” said Susan Galbraith, executive vice president of oncology R&D at AstraZeneca.

Radiotherapy and chemotherapy have been the mainstays of cancer treatment for decades. AstraZeneca has been working on other approaches to develop more targeted cancer treatments, including antibody-drug conjugates (ADCs) and RCs.

The U.S. Food and Drug Administration (FDA) first approved ADCs in 2000 and radioconjugates in 2018. AstraZeneca will also pay a non-transferable contingent value right of $3 per share, taking the combined transaction value to about $2.4 billion.

Fusion announced in January that it has aligned with the FDA on its submitted Phase 2/3 protocol for FPI-2265, with a Phase 3, or late-stage, registrational trial expected to begin in 2025.

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

AstraZeneca eyes growth in 2024 as portfolio expands

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

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AstraZeneca expects to boost revenue and profit this year on the back of resilient demand for its cancer and rare disease drugs, the company said on Thursday after reporting slightly lower than expected fourth-quarter profit.

In almost a decade since AstraZeneca fended off a takeover by US rival Pfizer CEO Pascal Soriot has rebuilt the Anglo-Swedish drugmaker’s pipeline, including blockbusters such as lung cancer drug Tagrisso, leukaemia drug Calquence and Farxiga for diabetes.

AstraZeneca’s RSV shot, co-developed with Sanofi, is also a break from its oncology expertise. Its diversification gathered pace with several acquisitions in 2023 and a licensing deal in November that took it into the booming anti-obesity drug market.

Tagrisso sales grew 9% last year while revenue from Imfinzi, another cancer drug, jumped 55% and Calquence sales rose by 23%.

The London-listed company said it expects total revenue and core earnings per share (EPS) to increase by percentages in the low teens this year.

Though the drugmaker reported slightly better than expected fourth-quarter revenue, profit was short of analyst estimates, hurt by a step up in R&D investment and price reductions for some medicines in emerging markets.

That sent shares of the FTSE 100 constituent down 1.5% in early trade.

“We expect another year of strong growth in 2024, driven by continued adoption of our medicines across geographies,” Soriot said.

AstraZeneca is also viewed as a bellwether for China’s pharmaceuticals sector, given its strong presence in the region. Revenue in China ticked up 16% in the final quarter of 2023 to $1.38 billion.

JP Morgan analysts said the strong outlook should dispel concerns among some observers about slowing growth.

Other analysts, including those at Citi and Jefferies, flagged some potential issues for 2024, including fewer than normal major research and development updates expected from the drugmaker.

“We have some longer-term concerns over the therapeutic diversification within the company, however strong the underlying talent and science,” Citi said in a note.

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

AstraZeneca to invest $300 million in US facility for cell therapies

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

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AstraZeneca said on Tuesday (February 6) it will invest $300 million in a facility in Rockville, Maryland for the discovery and development of cell therapies.

More than 150 jobs will be created at the site in the United States to initially focus on manufacturing the cell therapies to enable clinical trials to be conducted, the company said, adding that the site may expand its focus to support other disease areas.

The Rockville facility marks the latest investment for AstraZeneca in cell therapies after it acquires Neogene Therapeutics and other agreements with cell therapy developers.

AstraZeneca is advancing early-stage trials of several cell therapies in different types of cancer including liver and prostate cancer.

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

BioNTech challenges AstraZeneca with breast cancer precision drug trial, says report

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

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BioNTech and its partner Duality Biologics said on Monday, January 22, they initiated a late-stage trial testing their precision drug against a certain type of breast cancer, taking on a rival partnership between AstraZeneca and Daiichi Sankyo, news agency Reuters said in a report.

In a joint statement with China’s Duality, COVID-19 vaccine maker BioNTech said that their drug would be tested on women with a certain type of advanced breast cancer with low levels of a cell surface receptor known as HER2, it added.

HER2 is a common mechanism of tumour growth that has been targeted by established drugs such as Roche’s, opens new tab Herceptin, the report said. Partners Astra and Daiichi have taken the concept further with their leading drug Enhertu, based on the antibody-drug conjugate technology, a type of high-precision chemotherapy, it added.

That drug is expected by analysts to generate several billions of dollars in annual revenue, mainly because the drug has been approved to treat a larger population of HER2-type breast cancer patients, to include women with low levels of the receptor, the Reuters report said.

BioNTech and Duality said the new Phase III trial would test their drug—also an antibody-drug conjugate—on patients whose tumours grow in response to the hormones oestrogen or progesterone and which have low levels of HER2, the report said.

About 40% to 45% of all patients suffering from metastatic breast cancer meet those criteria, they added.

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

AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

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

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AstraZeneca said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market.

The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on December 22.

The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met.

Shares of China-headquartered Gracell surged 60% in premarket trading in the United States.

Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body.

H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s way of getting more into cell therapy as it is not as heavily involved in the space like Novartis (NOVN.S) and Gilead (GILD.O).

AstraZeneca will also acquire Gracell’s cash, cash equivalents and short-term investments of $234.1 million as of Sept. 30, 2023. The deal is expected to close in the first quarter of 2024, according to the statement.

AstraZeneca, one of the biggest drugmakers in China, had drafted plans to spin off its business in the region, according to media reports in June.

Last month, AstraZeneca agreed to a licensing deal for an experimental anti-obesity pill from China’s Eccogene, and in August it announced a contract manufacturing deal with CanSino Biologics for its messenger RNA technology vaccine program.

AstraZeneca signed three licensing deals with Chinese companies, CEO Pascal Soriot said earlier this year.

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

AstraZeneca to buy Chinese cancer drug developer for up to $1.2 billion

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

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AstraZeneca Plc agreed to acquire Chinese cell therapy developer Gracell Biotechnologies Inc. for as much as $1.2 billion as the British drug giant bolsters its bets on medical innovation in the world’s second-biggest economy.

Under the agreement, Astra will acquire Shanghai-based Gracell for $2 a share, amounting to an upfront cash payment of $1 billion. An additional share-purchase contingent on reaching certain regulatory milestones would eventually push the deal value to $1.2 billion, the companies said in a statement Tuesday.

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The acquisition will enrich Astra’s pipeline with a so-called CAR-T therapy that modifies a patient’s own immune cells to fight cancer. One candidate that Gracell has been working on, dubbed GC012F, could be a potential treatment for blood cancers such as multiple myeloma and autoimmune diseases like lupus, according to the statement.

The deal came after Astra struck a deal in November with Chinese biotech Eccogene Inc. to co-develop a weight loss pill, one of the hottest classes of medicine, as it seeks to contend with Novo Nordisk A/S and Eli Lilly & Co., two companies that have led the industry’s gold rush for obesity drugs.

While China is Astra’s second-largest market after the US, Chief Executive Officer Pascal Soriot has previously said the firm is keen to tap into the country’s medical innovation that’s prompted many pharmaceutical giants from developed nations to work with local drugmakers to co-develop promising drug candidates with blockbuster potential.

Gracell is able to meet the required regulatory milestones, Astra’s offer price of equivalent to $11.50 per American depositary share represents an 86% premium to Gracell’s closing price on Dec. 22. Shares in Gracell are up almost 170% this year.

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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

Breast cancer drug by AstraZeneca and Daiichi achieves study objective

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

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AstraZeneca said on Friday its experimental precision drug had slowed the progression of a common type of breast cancer in a late-stage trial, a boost for the company after its shares fell in July on results from a separate trial of the same drug for lung cancer.

The drug, datopotamab deruxtecan, which AstraZeneca is jointly developing with Japan’s Daiichi Sankyo, is being closely watched by analysts and investors in part due to the promise of the class of drugs to which it belongs, known as antibody-drug conjugates (ADC).

ADCs consist of tumour-seeking monoclonal antibodies that are combined with a cell-killing chemotherapy payload.

The trial data released on Friday showed the drug, abbreviated as Dato-DXd, demonstrated a statistically significant and clinically meaningful improvement in slowing the progression of a type of breast cancer in trial participants, compared to patients who received other treatments such as chemotherapy.

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The trial focused on tumours that grow in response to the hormones oestrogen or progesterone, which account for roughly two-thirds of breast cancer cases. The study participants’s disease had spread to other parts of the body.

The British drugmaker also said that there was a “trend in improvement” in the other main goal of the study, “overall survival” of patients, but the data on that was not mature so the trial would continue as planned.

AstraZeneca shares rose 1.7 percent in early trading, to their highest level in more than five weeks.

AstraZeneca is simultaneously developing the drug for use in lung cancer, and while data from a separate late-stage trial released in July was positive, the market was concerned that the drug’s benefits for use in lung cancer treatment might not as pronounced as hoped, leading shares to fall more than 6 percent on the day the data was released.

The company has not said when it will release detailed data from the lung cancer study.

Analysts see the positive results from the breast cancer trial as good for AstraZeneca, but the market is more focused on the results of a trial called MARIPOSA by Johnson & Johnson. It compares AstraZeneca’s blockbuster cancer drug Tagrisso alone with its own drug, Rybrevant, in combination with another medicine.

Those results are expected later this year.

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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

AstraZeneca Pharma India Q1 profit after tax jumps over two-fold

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

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AstraZeneca Pharma India Ltd on Monday reported over two-fold rise in profit after tax at Rs 53.86 crore for the first quarter ended June 30, 2023. The company had posted a profit after tax of Rs 20.15 crore in the same quarter last fiscal, AstraZeneca Pharma India said in a regulatory filing.

Revenue from operations during the quarter under review stood at Rs 295.46 crore, as against Rs 232.33 crore in the year-ago period, it added. Total expenses were higher at Rs 232.17 crore, as against Rs 209.14 crore, the company said.

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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