Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister.

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Express Pharma

JULY 3, 2023

Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology.

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pharmaphorum

OCTOBER 27, 2020

Pfizer is one of the front-runners in the race to approve a COVID-19 vaccine but the US company has had to weather lower revenues for the third quarter due to the ongoing impacts of COVID-19. Enbrel revenues, however, fell 21% internationally due to biosimilar competition in developed Europe markets, as well as in Japan and Brazil.

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Pharma Packaging Solutions

SEPTEMBER 22, 2023

For example, what is the difference between biologics and biosimilars? There are a few common types of biologics, including extracted (taken directly from a living system), semi-synthesized (produced with recombinant DNA technology), vaccines, and gene therapies. What are Biosimilars? That’s where biosimilars come in.

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Express Pharma

NOVEMBER 26, 2024

Namit Joshi, Vice Chairman, Pharmexil, said, “The Indian pharmaceutical industry has solidified its global position as the ‘Pharmacy of the World’ and earned recognition as the ‘Healers of the World’ through its exceptional contribution to COVID-19 vaccine distribution. With exports nearing $27.84

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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. The first therapy that delays the onset of type 1 diabetes received approval from the U.S. As of 2019, about 1.9

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Quality Matters

JUNE 17, 2024

Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? You’ve probably seen commercials for some of them on TV.

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Express Pharma

JANUARY 3, 2025

Investing in cutting-edge research, particularly in biosimilars, novel biologics, and cell and gene therapies, will be crucial. Serum Institute of India (SII) is the worlds largest vaccine manufacturer. India is the largest vaccine producer in the world and accounts for 60 per cent of the global vaccine production.

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pharmaphorum

FEBRUARY 8, 2022

Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. It’s time to suspend intellectual property and break vaccine monopolies,” said the campaign group’s pharma head Tim Bierley.

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pharmaphorum

MARCH 31, 2022

German injectable medicines specialist Fresenius Kabi has made a pair of deals to kickstart its new strategic direction, including a majority stake in mAbxience that bolsters its position in biosimilars. The post Deals build Fresenius Kabi’s position in biosimilars, medtech appeared first on.

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Pharmaceutical Technology

OCTOBER 28, 2022

Practising QbD in biosimilar product development. One area in which QbD should be practised is that of biosimilars, also known as follow-on biologics or subsequent entry biologics. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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PhRMA

MARCH 10, 2025

Measles was declared eliminated in the United States in 2000, thanks to widespread vaccination with the MMR vaccine. Unfortunately, in recent weeks, there has been an alarming increase in measles cases across the country – from Texas and New Mexico to New York and Rhode Island and the first reported death in a decade.

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Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. Another example is mRNA vaccines. In the past, scaling up the production of a new vaccine could take up to three years.

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European Pharmaceutical Review

NOVEMBER 6, 2023

Demand for cell lines “in drug development , vaccine production, and therapeutic research is surging”, setting the market up for significant expansion, Ghosh noted. The increased spending on biosimilar R&D from exiting biopharmaceutical companies would enhance the market, the report stated.

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Drug Channels

JUNE 27, 2021

As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing.

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pharmaphorum

AUGUST 25, 2022

The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business. billion by 2024.

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Express Pharma

JANUARY 12, 2024

With the Indian Pharma sector trying to reach the USD 130 Billion target by 2030, there is a renewed spirit of research in the areas of cell and gene therapy, biologics and biosimilars apart from the already strong generic and vaccine manufacturing sectors of the country.

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European Pharmaceutical Review

JULY 1, 2024

the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions” A positive opinion was granted to the mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine). The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). 1 virus variant.

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Pharmaceutical Business Review

APRIL 9, 2023

Located at the TÜBITAK MAM Gebze campus in Kocaeli province close to Istanbul, the MEDIBIYO facility can generate biotechnological drugs and vaccines that align with good manufacturing practice (GMP) standards, stated the Turkish publication. Ready to commence operation, this centre supports several industrial entities in the country.

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Pharma Leaders

APRIL 9, 2023

Marmara Research Center (MAM) and The Scientific and Technological Research Council of Türkiye (TÜBITAK) have commenced Medical Biotechnology Research Center (MEDIBIYO) for the production of drugs and vaccines on a pilot scale, reported Daily Sabah. Ready to commence operation, this centre supports several industrial entities in the country.

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PharmaTech

OCTOBER 18, 2024

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

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FDA Law Blog: Biosimilars

JANUARY 29, 2025

Aside from his many high profile claims about vaccines, what he perceives as corruption at FDA, and his promise to go wild on health, Kennedys specific policy preferences about how FDA should administer its day-to-day oversight of drugs, medical devices, food, dietary supplements, cosmetics, or tobacco have not been publicly detailed.

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Express Pharma

FEBRUARY 13, 2025

Scientific sessions focused on regulatory policies, mRNA technology, cell therapy, biologics and biosimilars, biomanufacturing, and analytical validation. The conference also featured BioPitch, a platform for biotech startups, and Catalyst Connect Hour, facilitating networking opportunities.

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Big Molecule Watch

AUGUST 21, 2023

alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY. 8,563,002, 11,261,239, 11,629,181, and 11,655,284, as claiming inventions relating to compositions used in RSV vaccines, and methods for preparing those compositions. Patent Nos.

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European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 percent from $3.45 trillion in Q2 2022 to $3.14 trillion in Q3 2022. percent and 16.2

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pharmaphorum

SEPTEMBER 8, 2020

In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.

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pharmaphorum

APRIL 30, 2021

billion, with vaccines sales falling nearly 19% to $1.8 It’s Merck’s last remaining COVID-19 programme after it scrapped development of its vaccine candidate and immune modulator MK-7110. Pharmaceutical sales were flat on the same period of 2020 at $10.7 Overall revenues for the quarter came in at $12.1

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Pharmaceutical Technology

DECEMBER 20, 2022

This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. However, the company is anticipated to experience recovery as it awaits regulatory approval from the FDA, expected in May 2023, after receiving priority review for its respiratory syncytial virus (RSV) vaccine.

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Express Pharma

OCTOBER 9, 2024

He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space. Reflecting on lessons from the last pandemic, he emphasised the importance of industrial capabilities, including manufacturing vaccines across multiple platforms.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US. billion between Dec 31, 2021 and Dec 31, 2022, owing to expansion in its vaccine and oncology portfolio.

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Express Pharma

DECEMBER 18, 2024

Additionally, the industry is set to make notable progress in cutting-edge areas such as CAR-T cell therapy, mRNA vaccines, and the development of complex molecules, which hold immense potential for driving future growth. The patent expiries of blockbuster biologics by 2025 present a significant growth avenue in the global biosimilars market.

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PharmaTech

JUNE 1, 2023

Biologics—including vaccines, cell and gene therapies, monoclonal antibodies (mAbs), and their biosimilars—have great potential for the treatment and prophylaxis of a broad range of diseases. But, rapid and efficient development of new and effective biologics is no easy feat.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

2014) June 2016 Vaxchora (Pax Vax Bermuda) Cholera vaccine for travelers $ 290 (June 2016) Aug 2017 Benznidazole (Chemo Research) Chagas disease UNK June 2018 Moxidectin (Medicines Devt for Global Health) Onchocerciasis, or river blindness UNK (May 2019) July 2018 Krintafel (GSK) P.

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European Pharmaceutical Review

APRIL 11, 2023

The key drivers of this industry include advancements in bioprocessing, development of novel microbial strains for production of high-value compounds and the rising demand for biopharmaceutical products such as antibiotics, vaccines and enzymes. There is a growing trend toward production of biologics and biosimilars.

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Drug Channels

FEBRUARY 22, 2022

New sections cover: pharmacies’ administration of—and profits from—COVID-19 vaccines; smaller PBMs; PBM purchasing groups and GPOs; 340b split-billing software vendors; and shakeout and consolidation within retail pharmacy. We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars.

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Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics.

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