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By PharmaCompass
2021-08-26
Impressions: 2,153 Article
This week, Phispers brings you more news on Covid-19 vaccines and boosters. The FDA has granted full approval to Pfizer-BioNtech’s Covid vaccine for people aged 16 and above, making it the first Covid-19 vaccine to pass this final regulatory hurdle.
Pfizer also strengthened its foothold in immune-oncology by acquiring Trillium Therapeutics for US$ 2.26 billion. In other oncology-related news, AbbVie and J&J won a key patent challenge against blockbuster cancer drug Imbruvica posed by New Jersey-based Alvogen and India-based Natco.
In regulatory news, after months, the FDA has posted Form 483s issued to Indian generic players Aurobindo and Jubilant Generics.
J&J’s CEO, Alex Gorsky, is passing the baton to Joaquin Duato, currently the vice chairman of the executive committee and the man in-charge of J&J’s Covid-19 response. J&J also announced data supporting the use of its single-dose Covid-19 vaccine as a booster.
In other Covid news, a South Korean study has found that people infected with the more transmissible delta variant have a viral load 300 times higher than those infected with the original version of the virus. And Israel has reduced the eligibility age for getting a booster dose of the Pfizer Covid-19 vaccine from 40 to 30 years, as it is beginning to see the benefits of administering the third dose.
Pfizer’s Covid jab bags FDA’s full approval; spurs vaccine mandates across US
This week began with the US Food and Drug Administration (FDA) granting full approval to Pfizer-BioNTech’s Covid vaccine for people aged 16 and above, making it the first Covid-19 vaccine to pass this final regulatory hurdle. According to experts, the approval could help ease vaccine hesitancy.
“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” acting FDA commissioner Janet Woodcock said.
The full approval replaces the emergency use authorization (EUA) granted by the FDA last December. Similarly, Moderna announced on Wednesday that it has completed the rolling submission process for its biologics license application (BLA) to the FDA for the full licensure of its Covid-19 vaccine and has also requested for a priority review.
The full approval to the Pfizer vaccine has already paved the way for more vaccination mandates. Following the full FDA approval, US President Joe Biden called on companies to mandate Covid-19 vaccines. “Today I’m calling on more companies in the private sector to step up the vaccine requirements,” Biden said.
Similarly, the Pentagon is preparing to issue updated guidance to require all US service personnel to be vaccinated. The Pentagon said it will seek the President’s approval by mid-September to require 1.3 million military members to get vaccinated against Covid-19.
Even schools are mandating vaccination. Officials have said that all New York City public school teachers and other staffers will have to get vaccinated against Covid-19.
While welcoming the FDA approval, Pfizer’s CEO Albert Bourla also stressed on the need for a booster. “The booster will be needed because of the combination of the delta variant ... and the fact that the immunity after six months starts waning.”
Meanwhile, Pfizer said a booster dose of its two-shot Covid vaccine spurs a more than threefold increase in antibodies against the coronavirus. Pfizer and its partner BioNTech aim to complete the FDA submission for the use of booster shots in people aged 16 and above by the end of this week.
Moderna withholds supply of 1.63 million doses of its jab in Japan: In a fresh setback to Moderna, whose partners had reported production delays last month, the drugmaker said it has withheld the supply of about 1.63 million doses of its Covid-19 vaccine in Japan. This comes after a report of contamination of vials with particulate matter, which it suspects involves a production line in Spain. Moderna said no safety or efficacy issues have been identified so far.
Pfizer buys clinical stage immune-oncology firm Trillium for US$ 2.26 billion
Pfizer has gradually built up its pipeline of experimental cancer medicines. This week, it signed an agreement to acquire Trillium Therapeutics, a clinical stage immuno-oncology company based in Cambridge, Massachusetts for US$ 2.26 billion.
In recent years, immunotherapies have gained prominence in the treatment of malignancies. Through this proposed acquisition, Pfizer gains access to Trillium’s early-phase inhibitors of the CD47 macrophage checkpoint. Macrophages are a key cell type in the innate immune response with CD47 being identified as a dominant macrophage checkpoint. In layman’s terms, CD47 is a “do not eat me” signal.
A number of other drugmakers are also going after CD47 with experimental cancer treatments, such as Forty Seven, which had been acquired by Gilead last year for US$ 4.9 billion. Similarly,
AbbVie and China’s I-Mab tied up last September and Boehringer Ingelheim and OSE Immunotherapeutics announced a global immuno-oncology partnership back in April 2018.
Others, such as Bristol Myers Squibb, Innovent Biologics and Zai Lab, have compounds in early stages of development.
Trillium’s two drugs are in early stages of clinical testing for a range of blood cancers, like lymphoma, as well as certain solid tumors. In September last year, Pfizer had invested US$ 25 million in Trillium as part of its breakthrough growth initiative.
Over the last few years, Pfizer has also supplemented its own R&D efforts with high-priced acquisitions. In 2016, it paid US$ 14 billion to buy Medivation and in 2019, it bought Array BioPharma for US$ 11.4 billion. Since 2015, seven Pfizer drugs have been approved to treat breast and lung tumors as well as leukemia — including the company’s top-selling cancer drug, Ibrance.
FDA posts Form 483s issued to Aurobindo and Jubilant Generics
After months, the US Food and Drug Administration (FDA) posted Form 483s issued to Indian drug manufacturers Aurobindo and Jubilant Generics.
The Form 483 issued to Aurobindo (Unit 1) in Telangana, indicates inspections have re-started in India after the summer lockdown as the FDA inspected the API manufacturing operations from August 2 to 12, 2021.
The six page list of observations highlights that Aurobindo failed to adequately qualify new suppliers for key starting materials (KSMs) used to produce APIs. In addition, the quality control unit failed to ensure that materials were appropriately tested, and changes to the manufacturing process were not evaluated to assess the potential quality impact on the product. In addition, as in many other 483s that have been posted, Aurobindo’s quality control unit failed to thoroughly investigate unexplained discrepancies in product behavior.
There were also concerns of data-integrity as complete reliability of quality-related documents was not assured because there was a failure to document quality-related activities at the time of performance. In one instance mentioned in the Form 483, a production operator was found to have written batch record information on his palm. The operator told the investigator that the information is written on the hand and then transcribed in the batch record.
In the case of Jubilant Generics, the FDA slammed them for their slate of cleanliness, quality control and record-keeping issues. The regulator put forth its seven-observations in the Form 483 after inspecting Jubilant’s Uttarakhand facility in India between March 2 and 12. In July, the site had been placed on an FDA import alert following the inspection.
The company doesn’t clean and maintain its equipment often enough to prevent malfunctions and contamination, the FDA said. On the first day of their inspection, FDA investigators found residue on a piece of non-dedicated equipment that had been marked as cleaned for product changeover.
Jubilant also didn’t lock up its computer systems to ensure production and control records could only be accessed by authorized personnel, and it failed to back up data altogether in certain cases, the FDA said.
“The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred,” the FDA said as a part of observation 7. “Specifically, your quality control unit failed to fully investigate errors that have occurred in order to support root causes identified.”
“Since December 2019, all US products undergo 100 percent automated visual inspection,” the Form 483 said. “Your current visual inspection process fails to assure that non-conforming tablets and capsules are rejected.”
J&J to get new CEO; announces data to support boosting its one-dose Covid vaccine
Johnson & Johnson’s (J&J) CEO, Alex Gorsky, will step away from his role in January and pass the baton to Joaquin Duato, currently the vice chairman of the executive committee and the man in-charge of J&J’s Covid-19 response.
During his nine-year tenure as CEO, Gorsky was swamped with vigorous legal battles — such as the talcum powder class action suits, and lawsuits pertaining to America’s opioid epidemic.
Just last month, J&J was considering a scheme to offload its multibillion-dollar talc liabilities into a new entity that would then file for Chapter 11 restructuring.
From January 3, Gorsky will take on the role of J&J’s executive chairman, a company statement said. In an interview with the Wall Street Journal, Gorsky said he was making the move due to “health issues.”
Duato will lead the company’s 136,000 employees worldwide and navigate the company through various ongoing litigations. Duato will also be appointed as a director on the company’s board.
Data supporting use of J&J’s Covid-19 vaccine as booster: J&J has announced data supporting the use of its Covid-19 vaccine as a booster dose for people previously vaccinated with the single-shot J&J vaccine. A booster six months after a single-dose J&J jab led to a nine-fold increase in spike-binding antibodies, CNBC reported.
“We have established that a single shot of our Covid-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months. With these new data, we also see that a booster dose of the Johnson & Johnson Covid-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson.
AbbVie, J&J win key patent challenge against blockbuster cancer drug Imbruvica
Back in March 2015, AbbVie Inc had bought Pharmacyclics Inc for about US$ 21 billion, thereby gaining access to Imbruvica, an oncology drug launched in 2013. At that time, Imbruvica was expected to be one of the world’s top-selling cancer drugs. With its acquisition, AbbVie not only expanded its reach in the profitable oncology field, but also lessened its dependence on its blockbuster rheumatoid arthritis drug Humira.
Since then, Imbruvica has bagged 11 FDA approvals and generated over US$ 5.3 billion for AbbVie and over US$ 4.1 billion in revenue for J&J last year.
Pharmacyclics owns the Imbruvica patents — the last of which is slated to expire in 2036 — and licenses them exclusively to J&J’s Janssen Biotech. In 2019, Janssen and AbbVie sued Pine Brook, New Jersey-based Alvogen and India-based Natco for patent infringement based on their application for FDA approval of a generic version of the drug.
Last week, AbbVie’s Pharmacyclics and Janssen Biotech won a ruling in Delaware federal court that four patents related to their blockbuster cancer drug Imbruvica are valid, in a dispute against Alvogen and Natco over a proposed generic version of the drug.
Alvogen and Natco agreed that their generic infringed three of the patents. The court rejected Alvogen and Natco’s “numerous” theories that the relevant parts of any of the four patents were invalid. The court ruling could keep generic versions of Imbruvica from hitting the US market for more than a decade.
‘People infected with Delta have 300 times higher viral load’, says study
A South Korean study has found that people infected with the more transmissible delta variant have a viral load 300 times higher than those with the original version of the Covid-19 virus, when symptoms are first observed.
But the viral load gradually decreases over time — to 30 times in four days and over 10 times in nine days — and it matched levels seen in other variants after 10 days, the Korea Disease Control and Prevention Agency (KDCA) said this week. The delta variant was first identified in India.
Higher load means the virus spreads far more easily from person to person, increasing infections and hospitalizations, Korea’s health ministry official Lee Sang-won said. “But it doesn't mean delta is 300 times more infectious...we think its transmission rate is 1.6 times the alpha variant, and about two times the original version of the virus,” Lee said.
Israel reduces eligibility age for booster: This week, Israel expanded its Covid-19 vaccine booster shots to those over 30 years, thereby broadening its booster campaign to fend off the delta variant of the novel coronavirus. According to the Israeli government, the decision to lower the age of eligibility for a third dose of the Pfizer-BioNtech vaccine from 40 to 30 years followed a recommendation from experts, its epidemiology task-force, and its vaccines committee.
Delta hit Israel in June, just as the country had opened its economy and scrapped curbs. Soon, the country went from single-digit daily infections and zero deaths to around 7,500 cases daily. On July 30, it began administering a third dose of the Pfizer vaccine to people over 60, becoming the first country to do so. Since then, Israel is seeing signs of a steady decline in the transmission of the virus.
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