Thu.Aug 04, 2022

Amgen bets almost $4B on a biotech and its inflammation drugs

Bio Pharma Dive

The deals hands Amgen a few clinical programs and a marketed therapy in Tavneos, which was approved last year to treat a group of autoimmune diseases

Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources.

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Pharma CEOs press case against drug price negotiation as bill gains support

Bio Pharma Dive

On earnings calls with investors, executives reiterated opposition to legislation advanced by Democrats that would curtail their pricing power in the U.S.

Drugs 169

How close are we to getting a male contraceptive?

Pharmaceutical Technology

With advances in clinical studies evaluating male contraceptives, and laws restricting abortion access after Roe v. Wade was overturned in the US, male contraception has been getting increased attention from the public.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Novo shares tumble after latest setbacks for closely watched obesity drug

Bio Pharma Dive

The Danish drugmaker lost tens of billions in market value after revealing a key clinical study for Wegovy won't be stopped early and production issues are still being ironed out

North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS).

US declares monkeypox a federal public health emergency

Bio Pharma Dive

“We're prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously,” HHS Secretary Xavier Becerra said Thursday

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Despite drug launch streak, Lilly posts rare sales decline as Alimta succumbs to generics

Fierce Pharma

Despite drug launch streak, Lilly posts rare sales decline as Alimta succumbs to generics. esagonowsky. Thu, 08/04/2022 - 09:03

Sales 94

Seqster, Boehringer Ingelheim, Partner up on Patient Engagement

Pharmaceutical Commerce

Multi-year deal aims to put patients at the center of their clinical data.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair.

Vaxess starts Phase 1 trial for H1 influenza vaccine patch

BioPharma Reporter

Vaxess Technologies has launched a phase 1 trial for its H1 influenza vaccine patch: outlining its mission to increase access to vaccines via the shelf-stable, sustained-release patch. Bio Developments

How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

Across the economy, several industries have seen a significant increase in staff turnover due to several factors including the COVID-19 pandemic, burnout, and increasing demand for workplace flexibility.

'The Top Line' podcast: Why early pandemic meds are throwing in the towel, how companies' pipelines have changed this earnings season, plus more

Fierce Pharma

The Top Line' podcast: Why early pandemic meds are throwing in the towel, how companies' pipelines have changed this earnings season, plus more. tcarey. Thu, 08/04/2022 - 12:56

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

The Qualities of a Great Webinar Presenter

XTalks

A great webinar presenter needs to have good communication skills to engage and connect with their audience, whether they’re in the same room as them or joining online.

RoslinCT and Lykan Bioscience combine to create advanced cell therapy CDMO

BioPharma Reporter

Edinburgh CDMO RoslinCT and Massachusetts CDMO Lykan Bioscience will combine to create a global advanced therapies CDMO: offering significantly expanded manufacturing capacity. Upstream Processing

Medical specialty societies can benefit from regulatory progress: IQVIA

Outsourcing Pharma

An expert from the trial tech firm explains how the 21st Century Cures Act and other recent regulatory advancements can elevate clinical data registries. Patient centricity

Poseida and Roche to develop cell therapies for hematologic cancers

Pharmaceutical Technology

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies.

Amgen splashes out on ChemoCentryx and its blockbuster hopeful

pharmaphorum

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 billion bid to buy out the company.

Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Pharmaceutical Technology

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People's Republic of China for usage in children of the age six months to three years.

Open Orphan to commence influenza human challenge study

PharmaTimes

Candidate exhibits a novel mechanism of action and differs considerably from previously approved drugs

Drugs 74

European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

The Pharma Data

Approval marks the first all-oral, once-daily, fixed-duration Bruton’s tyrosine kinase (BTK) inhibitor-based regimen for first-line treatment of CLL.

HR 52

COVID-19 health concern increases in July: Poll

Pharmaceutical Technology

The health concern over COVID-19 in July 2022 increased averaging at 27.7%, compared to 23.9% recorded in June 2022 , shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020.

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Amgen, on an M&A spree, inks $3.7B ChemoCentryx buyout to boost inflammatory disease presence

Fierce Pharma

Amgen, on an M&A spree, inks $3.7B ChemoCentryx buyout to boost inflammatory disease presence. Thu, 08/04/2022 - 09:50

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Business optimism declines in July 2022: Poll

Pharmaceutical Technology

Business optimism declined in July 2022 compared to June 2022, amid concerns over inflation as the cost-of-living pressures on households continued to grow in countries such as the UK, revealed the analysis of an ongoing poll by Verdict.

NHS leaders call for concrete proposals

PharmaTimes

Senior NHS figures fear that the leadership contest is not addressing wider health service needs

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Moderna reports total revenues of $4.7bn in Q2 2022

Pharmaceutical Technology

Moderna has reported total revenues of $4.7bn in the second quarter (Q2) of the fiscal year 2022 as against $4.4bn in the year-ago quarter. For the first half (H1) of the year, total revenue stood at $10.8bn, a growth from $6.3bn in the same period in 2021.

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Pfizer takes pipeline blow as it abandons cardiomyopathy drug

pharmaphorum

Pfizer has stopped development of a drug to treat cardiomyopathy caused by a rare form of heart disease, after it proved ineffective in a phase 3 trial.

ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)

FDA Law Blog

The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022. The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts.

People on the Move: August 2022

Outsourcing Pharma

This monthâs announcements of appointments, partnerships, expansions, and mergers include Curia, Thread, TFF Pharmaceuticals, and other notable companies. Markets & Regulations

ACI’s Paragraph IV Disputes Master Symposium – September 21-22, 2022 (Chicago)

FDA Law Blog

Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago!

New patent expiration for Collegium Pharm drug NUCYNTA

Drug Patent Watch

Annual Drug Patent Expirations for NUCYNTA Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. There are eight…. The post New patent expiration for Collegium Pharm drug NUCYNTA appeared first on DrugPatentWatch - Make Better Decisions.

Boehringer, Seqster ink 3-year health data deal to accelerate research

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the life-sciences tech firm in an effort to elevate data collection and speed up clinical studies. Clinical Development

New patent expiration for Collegium Pharm drug NUCYNTA ER

Drug Patent Watch

Annual Drug Patent Expirations for NUCYNTA+ER Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are…. The post New patent expiration for Collegium Pharm drug NUCYNTA ER appeared first on DrugPatentWatch - Make Better Decisions.