Pharmacist Digest

China’s CanSino seeks more vaccine contracts after AstraZenca deal

Express Pharma

AUGUST 31, 2023

. “This is the first step,” he said, describing the AstraZenca deal announced earlier this month as “a business model” “We do have discussions with not just the multinational giants, we also discuss with partners in Malaysia, Indonesia and Mexico, Argentina, any market that may need our technology and product.”

Vaccines

Vaccines Immunity Immunization

Coronavirus pharma news round-up 21/08/20

pharmaphorum

AUGUST 21, 2020

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. Here we highlight the biggest R&D, market access and digital coronavirus news of the past week.

Vaccines

Industry examining FDA guidance on nitrosamines

Quality Matters

AUGUST 22, 2023

Long-term exposure to these impurities can increase the risk of developing cancer and, because of this, they have been the subject of great interest and efforts by regulators around the globe to help the pharmaceutical industry control them.

Compounding

How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

DECEMBER 28, 2022

In pharma, multi-billion-dollar deals dominate M&A headlines, but most deals are far shorter of this range and generally lie between $10-$500 million. In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies

Standards support medicines supply chain resilience and the future of quality

Quality Matters

APRIL 20, 2023

Pharmacopeia (USP) help manufacturers, regulators, healthcare providers and others ensure quality throughout the pharmaceutical product lifecycle – from development through distribution – to support public trust in quality medicines. This enables efficient regulatory processes, timely product reviews, and faster market access.

Part One: Industry examining FDA guidance on nitrosamines

Quality Matters

AUGUST 23, 2023

Long-term exposure to these impurities can increase the risk of developing cancer and, because of this, they have been the subject of great interest and efforts by regulators around the globe to help the pharmaceutical industry control them.

Compounding

Pfizer files tick-borne encephalitis shot with FDA

pharmaphorum

FEBRUARY 25, 2021

Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting. The FDA has granted a Priority Review, where the regulator aims to make a decision within six months instead of the standard 10 month period.

Vaccines

Vaccines Immunity Immunization

Evaluate’s Orphan Drug Report 2022

pharmaphorum

JUNE 20, 2022

Paul Verdin, VP of consulting and analytics, and Andreas Hadjivasiliou, managing analyst at Evaluate, tell us about the company’s Orphan Drug Report 2022, which highlights activities within the orphan drug market and forecasts what the future of the industry holds based on data. Revising legislation. Positive projections.

Drug Legislation

The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

DECEMBER 13, 2022

Many excipients are manufactured outside of their major markets, ie, US, Japan and Europe; as such there should be transparency of the supply chain and proper flow of the necessary information. THE TRUTH PILL: The Myth of Drug Regulation in India. Cough syrup deaths expose lax drug regulation in India. The Lancet.

Compounding

Compounding Packaging

The data are in – so will Gilead’s Trodelvy achieve its potential?

pharmaphorum

MARCH 8, 2022

The company didn’t conduct a conference call to discuss the findings, but took the unusual step of publishing a frequency asked questions (FAQ) document on the study, headlined with a non-committal statement about whether the data were “clinically meaningful.”

Chemotherapy

Chemotherapy Documentation Labelling

Gilead’s remdesivir finally gets US approval

pharmaphorum

OCTOBER 23, 2020

Originally intended as a treatment for Ebola virus, remdesivir made headlines early on in the pandemic as the first drug to show significant improvements in recovery time in patients. The drug has already been approved by several other regulators across the world, including in the European Union and Japan.

Hospitals

Hospitals Labelling

Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

JANUARY 25, 2021

The immense amount of sharing — of data and expertise — among regulators around the world is expected to be the first step toward greater collaboration to help accelerate the launch of products globally. Sponsors may start to appreciate the benefits of allowing industry regulators to pull up a seat at the development table, for example.

Communication

Communication Drug Development

Vounatsos heading for exit as Biogen sidelines Aduhelm

pharmaphorum

MAY 3, 2022

The headline news in the company’s first-quarter results statement (PDF) was Vounatsos’ departure, although he will remain at the helm of Biogen until a new CEO is found to help oversee a revitalisation of the company. Michel Vounatsos. billion by completing the sale of its share in biosimilars joint venture Samsung Bioepis.

Biosimilars

Virtual and augmented reality: Bringing the future to pharma manufacturing

pharmaphorum

MARCH 22, 2022

Virtual reality (VR) and augmented reality (AR) have spent a lot of time in the headlines recently. New equipment and new operators are a constant in the market and staying ahead of the training curve is a necessity to achieve business outcomes.”.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies

Standards on the Frontlines: Responding to public health crises and strengthening supply chains

Quality Matters

OCTOBER 10, 2023

Standards on the Frontlines: Responding to public health crises and strengthening supply chains Vulnerabilities or disruptions to the global medicine supply chain (including drug shortages) continue to make headlines. Such testing is required by law for certain products marketed in the U.S.

Adverse Reactions

Adverse Reactions Compounding

Styles Of Copywriting for Medico-Marketing: Know The 6 Most Important!

PharmaState Academy

AUGUST 9, 2023

Written By: Vivek Hattangadi Crimes in Copywriting – Part 2 Styles Of Copywriting for Medico-Marketing: Know The 6 Most Important! The goal of medico-marketing copywriting is to build up the reputation of your brand and elicit an action from doctors. So also “What is the goal of your medico-marketing copy.”

Health and Personal Care Stores

Health and Personal Care Stores Communication Diabetes

UK life science competitiveness indicators 2022: measuring what matters most?

pharmaphorum

AUGUST 17, 2022

The median number of days between marketing authorisation and medicines being made available is included too. Better data has been emerging for England with expenditure estimates taking account of central rebates and at least England is the biggest share of the market, but there’s no headline figure for real spending for the UK.

Pharma in Brief: The 2022 Year in Review

Pharma in Brief

JANUARY 25, 2023

We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and accompanying rules/regulations. Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ).

Native Advertising is Exploding Across Healthcare, Have you Jumped In?

Pharma Marketing Network

NOVEMBER 3, 2021

In the last 2 years, and accelerated by Covid, native advertising has exploded across healthcare for DTC and HCP marketing. When it comes to moving the needle for your brand, your sales funnel, or script lifts, healthcare marketers agree that content marketing works best.

Use Quantitative Information for Consumer-Facing Promotion, FDA Guidance Says

Pharma Leaders

JUNE 27, 2023

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

China’s CanSino seeks more vaccine contracts after AstraZenca deal

Coronavirus pharma news round-up 21/08/20

Trending Sources

Industry examining FDA guidance on nitrosamines

How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

Standards support medicines supply chain resilience and the future of quality

Part One: Industry examining FDA guidance on nitrosamines

Pfizer files tick-borne encephalitis shot with FDA

Evaluate’s Orphan Drug Report 2022

The lingering menace of diethylene glycol / ethylene glycol adulteration

The data are in – so will Gilead’s Trodelvy achieve its potential?

Gilead’s remdesivir finally gets US approval

Clinical research in 2021: A new era of collaboration and innovation

Vounatsos heading for exit as Biogen sidelines Aduhelm

Virtual and augmented reality: Bringing the future to pharma manufacturing

Standards on the Frontlines: Responding to public health crises and strengthening supply chains

Styles Of Copywriting for Medico-Marketing: Know The 6 Most Important!

UK life science competitiveness indicators 2022: measuring what matters most?

Pharma in Brief: The 2022 Year in Review

Native Advertising is Exploding Across Healthcare, Have you Jumped In?

Use Quantitative Information for Consumer-Facing Promotion, FDA Guidance Says

FTC Slams District Court Decision, Supports Pharmacies in Bystolic Antitrust Case

GSK trumpets Jemperli vs Keytruda data in first-line NSCLC

CBER, CDER Directors Review Priorities and Challenges at FDLI Annual Conference

Califf: Diabetes, Weight Loss, Alzheimer’s Drugs Could Be “Major Game Changers”

FDA Seeks Feedback on AI and Machine Learning in Drug Development

Senate HELP Committee Votes to Send Four Drug Reform Bills to Full Chamber

FDA Final Guidance on Glycerin, High-Risk Drug Components Aims to Prevent Poisonings

MDSAP QMS Implementation Plan Highlights Ongoing Assessments and Improvements

FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes

Number of Overdue Priority Review ANDAs Dips in FY 2023

FDA Issues Final Guidance on Nicotine Replacement Therapies

Maker of Generic Abortion Pill Sues FDA to Prevent Potential Enforcement Actions

Warning Letters Trend Toward Component Testing, Contractor Oversight in 2022

Interview: CDER OND Director Stein on Novel Drugs, Expedited Approval Pathways

CBER Director Highlights Hiring Challenges, Other Issues Ahead for Fiscal 2024

FDA Requires Opioids Producers to Supply Mail-Back Envelopes for Disposal

Jury Says Sandoz Owes $39M for Eyelash Drug Patent Infringement

Drug Supply Chain is Vulnerable to Threats, Says Senate Committee

Better Matching of Patients to Oncology Drugs is Goal of New FDA Pilot Project

EU GMP Report — June 2023

FDA Calls on Xeris to Correct Misleading Safety and Efficacy Claims

FDA Guidance Outlines GDUFA III Fee Program Changes

FDA Moves Ahead With PDUFA VII Commitments on Real-World Evidence

FDA Issues Development Program Guidances to Assist Drug, Device Sponsors

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