pharmaphorum

JULY 9, 2021

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . Myocarditis is generally the result of a viral infection, so could be unrelated to the mRNA vaccines, particularly as neither of them contain any live virus.

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STAT

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 The first therapy that delays the onset of type 1 diabetes received approval from the U.S.

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The Checkup by Singlecare

MAY 6, 2024

Gardasil 9 is a brand-name vaccine used to protect against nine types of human papillomavirus (HPV). So, who should get the HPV vaccine, and what is the Gardasil 9 dosing schedule? Who is the HPV vaccine for? This vaccine is routine and recommended for everyone, all genders, ages 9–26,” says Christina M. Madison, Pharm.D.

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STAT

OCTOBER 27, 2022

The investigation began in February and covers 2017, 2018, and 2019. The Italian branch allegedly sent the capital to foreign affiliates linked to a units based in Delaware called Pfizer Production and Pfizer Manufacturing. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

MAY 15, 2023

million global hospitalisations in 2019. Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. RSV is the most common cause of LRTD. Other companies are competing in the RSV therapy space, too.

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pharmaphorum

MARCH 3, 2022

Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. AZ, Sanofi antibody aces phase 3 trial. Last year, sales were around $273 million.

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pharmaphorum

MAY 13, 2022

Way back in January 2020, Pfizer’s 2019 annual report could only note the potential disruption from a novel strain of coronavirus. In March 2020 Pfizer began collaborating with BioNTech on a vaccine for COVID-19 and 269 days later it received emergency use authorisation from the FDA.

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pharmaphorum

MARCH 9, 2021

Regeneron and Eli Lilly have already got antibody therapies on the market following emergency approvals by regulators including the FDA but pharma companies are beginning to focus on the threat posed by emerging variants. Ablynx, which is now a subsidiary of Sanofi following a $4.8

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pharmaphorum

AUGUST 8, 2022

Oxbryta came to market in 2019, a few days after Novartis’ injectable anti-P-selectin antibody Adakveo (crizanlizumab), which is also tipped for blockbuster sales but like Oxbryta has suffered from a slow rollout. It comes shortly after the group closed a $6.7

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Pharmaceutical Technology

DECEMBER 16, 2022

Novel therapeutics and vaccines for malaria. As per the WHO’s 2022 malaria report , 63,000 malaria deaths were attributed to Covid-19-caused disruptions to services from 2019–21. In the same month, GSK’s malaria vaccine Mosquirix received prequalification from the WHO, bringing it closer to a rollout in children.

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The Checkup by Singlecare

AUGUST 6, 2024

Remicade: Key differences Remicade, made by the pharmaceutical company Janssen Biotech, was approved by the Food and Drug Administration (FDA) in 1998. According to the FDA , most biologics are complex mixtures that cannot be easily characterized or identified. They are also FDA approved for the same indications.

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European Pharmaceutical Review

JULY 17, 2023

The $82 million project is funded by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. This $85 million programme ran between 2007 and 2019. This new pilot-scale system builds on success of the Novartis-MIT Center for Continuous Manufacturing.

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pharmaphorum

DECEMBER 22, 2021

Japanese drugmaker Takeda has suffered a blow to its late-stage pipeline, after the FDA rejected its marketing application for TAK-721, a drug candidate that is trying to be the first approved therapy in the US for eosinophilic oesophagitis (EoE). Takeda acquired the drug as part of its $62 billion merger with Shire in 2019.

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pharmaphorum

JANUARY 5, 2021

Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at. Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June.

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pharmaphorum

MAY 11, 2022

If approved, nirsevimab would provide a new option for managing RSV, ahead of the possible rollout of vaccines that could be used to protect young children. Despite the RSV vaccine threat, analysts at GlobalData have predicted that nirsevimab could reach $3 billion in annual revenue by 2030, assuming a launch next year.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

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ISPE

JUNE 6, 2023

Our speakers will give insights on hospital manufacturing and commercial manufacturing of ATMPs/C>s, including networking opportunities and a panel discussion with all speakers from the track featuring Peter Marks from the FDA as a special guest speaker.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. But we digress.

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pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. About the interviewee.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Opdivo is a programmed cell death receptor-1 (PD-1) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of several cancers. Against the backdrop of these therapeutic approaches, the launch of India’s new HPV vaccine Cervavac adds to the armamentarium of vaccines to prevent cervical cancer.

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pharmaphorum

FEBRUARY 23, 2022

The global health crisis caused spending on healthcare to increase , due to the funding provided to the development and purchases of vaccines and treatments, as well as support provided for the associated infrastructure. In 2020, AMA’s research showed that savings from the use of biosimilars tripled from 2019.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.

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pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. We measured the pandemic impact on the launch of NAS at four levels.

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Pharmaceutical Technology

APRIL 4, 2023

Manufacturing growth in the region Since our last analysis in 2019 (‘Andhra Pradesh and Telangana: Indian Contract Manufacturing Powerhouses for US API Supply’, EMOR, September 2019), the two states have opened an extra 49 manufacturing sites for foreign markets. © GlobalData. ©GlobalData.

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pharmaphorum

AUGUST 8, 2022

If confirmed, it will be another example of Pfizer leveraging the windfall cash generated by its COVID-19 vaccine Comirnaty and oral antiviral therapy Paxlovid to beef up its pipeline of new therapies, coming a few months after it closed a $6.7 billion acquisition of Arena Pharma and made an $11.6 billion takeover bid for Biohaven.

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pharmaphorum

JANUARY 31, 2022

Pfizer paid $250 million upfront for rights to vupanorsen in 2019, in a deal that had another $1.3 There were however also some worrying safety signals, including increases in liver fat and enzymes, that seemed to be dose-dependant, linking them to drug treatment, which were referenced by Pfizer in its statement on the decision.

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ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. Also having enough glass vials to put the vaccines in!

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pharmaphorum

SEPTEMBER 8, 2020

Governments do not have to look hard to find ample opportunity for their health systems to accelerate biosimilar adoption practices and drive huge healthcare savings while still delivering excellent high quality patient care, as noted openly by the FDA during the last 18 months. Published 8 March 2019. Published 25 November 2019.

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pharmaphorum

JANUARY 27, 2022

Belgium-born Stoffels will join Galapagos after a challenging period for the company, which is in the throes of launching its JAK1 inhibitor Jyseleca (filgotinib) for rheumatoid arthritis in Europe and Japan, but not the US after the FDA rejected the drug amid safety concerns.

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The Checkup by Singlecare

MAY 16, 2024

According to the FDA , biologics are complex mixtures that cannot be easily characterized or identified, whereas nonbiologic drugs are made with chemicals and have a known structure. Before being FDA approved, biosimilars are clinically tested to ensure they are as safe and effective as the reference product. What are biosimilars?

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PharmaShots

MAY 23, 2023

Stock Exchange: TYO With focus areas extending to the discovery and development of biopharma products, AnGes is dedicated to developing genetic medicines and therapeutic vaccines for intractable or rare diseases. The company received its first approval from the Japanese government in 2019 to treat critical limb ischemia.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.

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Roots Analysis

MARCH 13, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. It is worth mentioning that 60% of the deals were established post-2019.

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