2009 and Documentation - Pharmacist Digest

Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case

STAT

APRIL 6, 2023

South San Francisco biotech Genentech on Thursday announced that an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and Stanford University’s current president, did not find any evidence of fraud or intentional wrongdoing.

Documentation

STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

STAT

OCTOBER 16, 2023

The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertising databases, leaked documents, and research reports.

Documentation

STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed by 2030 , according to FDA briefing documents published earlier this week.

Documentation

SAEM Clinical Images Series: Fever with Rash

ALiEM - Pharm Pearls

JANUARY 22, 2024

Fever was documented to be 102°F and was not associated with any chills or rigors. 2009 Jan;11(1):66-72. A 40-year-old male, tailor by occupation, was brought to the Emergency Department with complaints of high-grade fever for the past 11 days. Infect Dis Clin North Am. 2007 Dec;21(4):997-1011, ix. doi: 10.1016/j.idc.2007.08.002.

Documentation

Documentation Hospitals

Driving QbD as a quality standard in drug development

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Drug Development

Drug Development Biosimilars Documentation

Tick Tock re Tik Tok and FDA’s OPDP

Eye on FDA

OCTOBER 19, 2022

And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. In fact, the medium does matter.

Communication

Communication Documentation

From genes to greens: Recombinant revolution in nutraceuticals

Express Pharma

JANUARY 14, 2024

It was not until 2009 that the European Medicines Agency (EMA) published a ‘Guideline on the quality of biological active substances produced by stable transgene expression in higher plants.’ Regulatory The fact that plant biotechnology is still in its early stages, recombinant nutraceutical manufacturing is complicated.

Documentation

Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

Documentation

Documentation Pharmaceutical Companies Pharmaceutical Companies

FDA OPDP Look Back at 2021 – The Yawning Gap

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. in November 2009.

Communication

Communication Documentation Labelling Pharmaceutical Companies

Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

Packaging

Packaging Documentation Communication Pharmaceutical Companies

Case Study 1 – Establishment of a Long-Term Medical Writing Partnership

Syner-G

AUGUST 21, 2022

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.

Documentation

Documentation Pharmaceutical Companies Pharmaceutical Companies

Increasing patient engagement with UK clinical trials

pharmaphorum

NOVEMBER 17, 2020

Keith Wilson is a former heart patient who has worked on a voluntary basis, over many years with various organisations and researchers, promoting Public and Patient involvement to enhance the clarity of documentation and participation in Research. Gareth has been with the Clinical Research Network since 2009.

Documentation

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals

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

pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. In the last 15 years, there has been a noticeable shift towards many prominent players effectively outsourcing innovation to start-ups due to the increasing cost of R&D.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies

Ardelyx’s ambition to revolutionise kidney treatment

pharmaphorum

DECEMBER 17, 2020

As the co-founder of the biopharma company, Raab has been focusing on advancing patient care for kidney disease since 2009. While Ardelyx awaits FDA approval for Tenapanor, it is moving forward with regulatory approval internationally and has filed documents with the European Medicines Agency (EMA).

Documentation

Documentation Diabetes

EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

Biosimilars

Biosimilars Labelling Documentation

Anas Batikhi, Founder & CEO at Santechture Shares on RCM-Tech, A Necessity in The Healthcare Industry

PharmaShots

JUNE 2, 2023

THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks. Formed as a spin-off into a standalone company in 2019, the firm has a proven legacy as a center of excellency in the healthcare RCM Tech domain since its inception in 2009.

Insurance Coverage and Processing

Insurance Coverage and Processing Health and Personal Care Stores Medical Records Documentation

NICE talking to you: Trends in early HTA engagement

pharmaphorum

OCTOBER 29, 2020

In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA).

Documentation

Documentation Drug Development

Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] Published 2009 Mar 10. [15] 2009; 1(2); 143-149. [22] Int J Physiol Pathophysiol Pharmacol. 2009;1(2):143-149. 22] Shokri H. Avicenna J Phytomed.

Diabetes

Diabetes Dosage Compounding Immunity

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. Nor did FDA give notice that favored product manufactures had to submit robust scientific studies on flavored cigarette products.

Documentation

The Lilly Digest

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?). prescription transaction.

Independent Pharmacies

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling

EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

NOVEMBER 27, 2020

Teva said in a statement: “The Commission started investigating this agreement in December 2009. Examples included a “lucrative” supply contact earning Teva at least five million euros in profits, even though Cephalon could cover its needs without the additional supplies.

Packaging

Packaging Documentation

Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

Eye on FDA

JULY 7, 2020

The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications. OPDP has indicated in the past that the use of sponsored links without risk information is a no-no.

Communication

Communication Documentation Labelling Pharmaceutical Companies

NHC’s comments in response to the 2025 Notice of Benefit and Payment Parameters (NBPP)

Putting Patients First Blog

JANUARY 10, 2024

9,10,11 The current verification process poses substantial challenges for formerly incarcerated individuals, who often encounter difficulties in securing necessary documentation and employment. These resources should include guidelines on qualifying life events, necessary documentation, and deadlines. Retrieved from https ://w ww.

Insurance Coverage and Processing

Insurance Coverage and Processing Communication Documentation Diabetes

Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. 2010;20(7):755-761. doi:10.1089/thy.2010.1636.

Health and Personal Care Stores

Health and Personal Care Stores Compounding Immunity Immunization

Solutions to Increase Low Libido in Those with Hashimoto’s

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2009-0041.

Dosage

Dosage Documentation Diabetes Labelling

FDA sketches a path for patient-focused drug development

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

Drug Development

Drug Development Documentation Communication

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis.

Documentation

Documentation Hospitals Dosage Drug Pricing

Pharmacist Digest

Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case

STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

Trending Sources

STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

SAEM Clinical Images Series: Fever with Rash

Driving QbD as a quality standard in drug development

Tick Tock re Tik Tok and FDA’s OPDP

From genes to greens: Recombinant revolution in nutraceuticals

Biogen’s $900 million settlement signals scrutiny on speaker fees

FDA OPDP Look Back at 2021 – The Yawning Gap

Bridging the healthcare digital divide: a gradual approach to adopting ePI

Case Study 1 – Establishment of a Long-Term Medical Writing Partnership

Increasing patient engagement with UK clinical trials

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

Ardelyx’s ambition to revolutionise kidney treatment

EU pharmaceutical legislation revisions: what are the implications for biopharma?

Anas Batikhi, Founder & CEO at Santechture Shares on RCM-Tech, A Necessity in The Healthcare Industry

NICE talking to you: Trends in early HTA engagement

Black Seed Oil and Hashimoto’s

The Most Engaging Decision You’ll Read All Year – Five Stars

The Lilly Digest

EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

NHC’s comments in response to the 2025 Notice of Benefit and Payment Parameters (NBPP)

Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

Solutions to Increase Low Libido in Those with Hashimoto’s

FDA sketches a path for patient-focused drug development

Exforge antitrust settlement caps Novartis’ year of legal disputes

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