Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

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Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Depending on the type of product and its purpose, secondary packaging materials ensure the stability and integrity of the investigational medicinal product.

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Pharmaceutical Technology

OCTOBER 12, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on valproate-containing medicines.

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Bio Pharma Dive

FEBRUARY 21, 2023

Many current top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.

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Pharma Times

FEBRUARY 7, 2024

The new products are in the areas of gastrointestinal and respiratory medicines

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Pharmaceutical Technology

OCTOBER 18, 2023

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

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Bio Pharma Dive

MARCH 4, 2024

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

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Pharmaceutical Technology

NOVEMBER 15, 2024

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).

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Pharmaceutical Technology

JULY 29, 2024

EMA’s COMP has adopted positive opinions for two orphan medicinal product designations for Attralus’s AT-02.

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FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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Pharmaceutical Technology

MARCH 4, 2024

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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NPR Health - Shots

DECEMBER 3, 2022

Makers of products like Children's Tylenol say they're trying to keep up with big demand as RSV, flu, and COVID spread. But medical experts note that kids' fevers don't always call for medicine. Image credit: Laurel Wamsley/NPR)

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Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

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Bio Pharma Dive

JULY 11, 2022

Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.”

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Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Bio Pharma Dive

JANUARY 17, 2023

The pharma is now committing to providing all of the roughly 500 products in its portfolio, including antibiotics and cancer drugs, to 45 lower-income countries.

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Pharmaceutical Technology

DECEMBER 15, 2022

Medicines experience a 16% price drop on average post-ATU/early access. GlobalData identified 17 medicines, including eight orphan medicines, that were first available under an early access programme or previous ATU and that are now priced under standard pricing and reimbursement procedures.

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Pharmaceutical Technology

MARCH 17, 2023

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Furthermore, today’s announcement presents a rare opportunity to license in a medicine that naturally synergises with one of the core growth products in our current portfolio.”

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Bio Pharma Dive

NOVEMBER 27, 2023

billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy. The planned $2.3

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Pharmaceutical Technology

JUNE 29, 2022

For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The next wave of medicine is well on course to be cell and gene-based. What Pharmatech does is translate the customer needs into a desirable product profile.

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Drugs Gene Therapy Production Manufacturing 295

Outsourcing Pharma

MAY 29, 2024

UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.

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Pharmaceutical Technology

JULY 21, 2022

It also received an orphan medicinal product designation from the European Commission (EC) to treat MDS in the EU. The EC designation comes after the Committee for Orphan Medicinal Products (COMP) provided an opinion on the designation. MDS are a group of diseases characterised by ineffective blood component production.

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Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The Institute for Protein Design (IPD) of the University of Washington School of Medicine is also involved in the development of SKYCovion.

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Pharmaceutical Technology

JUNE 19, 2023

Oral liquid medicine manufacturer Rosemont Pharmaceuticals has announced the acquisition of Lucis Pharma. UK-based Rosemont hopes that this latest acquisition will bolster its portfolio with a pipeline of innovative products and allow it to serve the UK and overseas markets.

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Pharmaceutical Technology

AUGUST 12, 2022

Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction. Following the introduction of customs controls in January 2021, medicine imports from the EU fell to their lowest levels in years. Changes to batch testing requirements.

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Pharmaceutical Technology

JUNE 12, 2023

Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure.

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Drug Patent Watch

MARCH 18, 2025

The Russian pharma market has experienced significant growth in recent years, driven by a combination of factors, including government support, increasing healthcare spending, and a focus on domestic production. With the Russian government's support for domestic production, biosimilars are becoming increasingly important in the country.

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Pharmaceutical Technology

JANUARY 20, 2023

And delays in the supply chain, even for short periods of time can potentially affect the efficacy of medicines, lead to longer-term supply bottlenecks, and ultimately prevent people from getting access to the critical medicines they need. Pharma manufacturing can also be affected by extreme weather events, such as storms.

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Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

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Rethinking Clinical Trials

JANUARY 6, 2025

Rhon is a professor of rehabilitation medicine at the Uniformed Services University of the Health Sciences. Registration is required for participation this live web conference, but there is no cost. Continuing education credits are available for several disciplines for participants who are affiliated with the VA.

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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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Pharmaceutical Technology

FEBRUARY 27, 2025

Eli Lilly has announced plans to expand its domestic medicine production in the US with four new pharmaceutical manufacturing sites.

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Pharmaceutical Technology

JULY 25, 2022

As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman. But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds.

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Pharma Times

APRIL 12, 2024

Both partners’ will leverage their nuclear research facilities and expertise to develop new health interventions

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Pharmaceutical Technology

MARCH 26, 2025

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monthly safety bulletins aimed at making medical device and medicine safety information clearer and more accessible for healthcare professionals.

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Pharmaceutical Technology

MARCH 20, 2023

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. RVAC Medicines CEO Dr Sean Fu said: “We are excited to begin this collaboration with Dr Weissman, a pioneer in the field of mRNA vaccines and therapeutics.

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