Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. patients undergoing such surgeries today receive an opioid, and given the increasing number of opioid-related deaths, this approval is indeed good news.

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Drug Discovery World

APRIL 23, 2024

The UK’s National Institute for Health and Care Excellence (NICE) has published draft guidance recommending the use of Nexpovio (selinexor), in combination with bortezomib and dexamethasone, as a treatment for eligible multiple myeloma patients who have received one or two prior treatments.

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Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The guidance lists questions and answers for the following topics: Bracketing/matrixing. In the News: August 2021 Regulatory and Development Updates.

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pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. It has drawn up the guidance with the help of the companies, the ABPI, and UK regulator the MHRA.

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Drug Discovery World

JUNE 9, 2023

News round-up for 5-9 June by DDW Digital Content Editor Diana Spencer. FDA announces additional steps to modernise clinical trials The US Food and Drug Administration has published draft guidance with updated recommendations for good clinical practices (GCPs) to modernise the design and conduct of clinical trials.

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Pharma in Brief

JUNE 20, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 ( Interim Guidance ). 1] The Board has also provided an update on a forthcoming consultation regarding new Guidelines.

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Pharma in Brief

OCTOBER 26, 2023

As we reported , the PMPRB has been operating under an Interim Guidance, which was recently amended to provide additional guidance on new medicines introduced during the Interim Period until new guidelines are introduced.

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FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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BioTech 365

OCTOBER 20, 2021

Ipsen Delivers Strong Sales Growth for the First Nine Months and Improves Its Full-Year Guidance Ipsen Delivers Strong Sales Growth for the First Nine Months and Improves Its Full-Year Guidance PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global … Continue reading →

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Drug Discovery World

JUNE 12, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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Drug Discovery World

JUNE 12, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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BioTech 365

JULY 28, 2021

Ipsen Delivers Strong H1 2021 Results and Upgrades Full-Year Guidance Ipsen Delivers Strong H1 2021 Results and Upgrades Full-Year Guidance PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today announced its financial results for the … Continue reading (..)

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World of DTC Marketing

MARCH 2, 2022

For investors that had just become accustomed to getting mid-to-high 30s% CAGR growth, management to so bluntly signal to investors that after 2022, its growth rates will slow down slightly is terrible news at an awful time. Investors wanted to be blown away by its guidance.

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Drug Discovery World

APRIL 11, 2024

The decision by the SMC follows final draft guidance by the National Institute for Health and Care Excellence (NICE). This means that dostarlimab is the first immunotherapy treatment to be accepted for use within NHS Scotland for this group of eligible patients.

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The Pharma Data

DECEMBER 4, 2020

NHLBI Updates Guidance for Management of Asthma. In addition, guidance is provided for the use of methods to reduce exposure to indoor asthma triggers; use of the fractional exhaled nitric oxide test to help manage asthma or confirm diagnosis in some patients; and use of bronchial thermoplasty to treat selected adults with persistent asthma.

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Advarra

NOVEMBER 17, 2022

On September 26, 2022, the FDA published a draft guidance summarizing ethical considerations for conducting clinical trials involving children. The FDA’s draft guidance intends to provide industry, sponsors, and institutional review boards (IRBs) with insight into protecting children who participate in clinical investigations [2].

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BioTech 365

JANUARY 6, 2022

DGAP-News: MorphoSys AG / Key word(s): Forecast 07.01.2022 / 07:59 The issuer is solely responsible for the content of this announcement. Sales and Provides 2022 Financial Guidance … Continue reading → Media Release Planegg/Munich, Germany, January 07, 2022 MorphoSys Reports Preliminary 2021 Monjuvi U.S.

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BioTech 365

DECEMBER 8, 2021

DGAP-News: Biotest AG / Key word(s): Profit Warning 08.12.2021 / 19:45 The issuer is solely responsible for the content of this announcement. PRESS RELEASE Biotest adjusts guidance Demand for drug therapies with coagulation factors cannot keep up with the enormous … Continue reading →

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Pharmaceutical Technology

SEPTEMBER 26, 2022

With the publication of the final draft guidance by the institute, the combination therapy will be offered for routine use in the National Health Service (NHS). An inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6), palbociclib is administered once a day as a pill.

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BioTech 365

DECEMBER 1, 2021

DGAP-News: ABIVAX / Key word(s): Study 01.12.2021 / 19:30 The issuer is solely responsible for the content of this announcement. Abivax receives FDA feedback with guidance on advancing ABX464 into phase 3 clinical testing in ulcerative colitis End-of-phase-2 response from … Continue reading →

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Guidance Issued on Referencing Approved Drug Products in ANDA Submissions. Co-Authors: Jenny Fielder. Manager of Regulatory Compliance. Ken Phelps.

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Drug Discovery Today

FEBRUARY 3, 2021

Recent news about Greg Rutherford’s detection of a cyst is a reminder that it is important for men to get regular check-ups. If you have concerns and questions the book provides clear and helpful advice with useful instruction and guidance on what to look for and how to do a self-examination. February 4th is World Cancer Day.

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BioTech 365

JUNE 28, 2021

DGAP-News: Vivoryon Therapeutics N.V. / Vivoryon Therapeutics Provides Update on Financial Guidance Halle (Saale) / Munich, Germany, June 29, 2021 – Vivoryon Therapeutics … Continue reading → Key word(s): Miscellaneous 29.06.2021 / 01:11 The issuer is solely responsible for the content of this announcement.

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Camargo

SEPTEMBER 15, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. FDA issues guidance on inspections during COVID-19 pandemic. Fitbit developing algorithm COVID-19 early detection. Co-Authors: Ken Phelps.

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XTalks

OCTOBER 14, 2021

This guidance is intended to provide measurable voluntary short-term (2.5-year) More than 70 percent of total sodium intake is from sodium added during food manufacturing and commercial food preparation,” the FDA said in the same guidance document. “We That requires thinking about the food we eat – or, better put, the food we don’t.

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BioTech 365

MARCH 24, 2021

DGAP-News: Evotec SE / Key word(s): Annual Results 25.03.2021 / 07:00 The issuer is solely responsible for the content of this announcement. VERY STRONG FINANCIAL RESULTS: 12% INCREASE IN GROUP REVENUES BEATING GUIDANCE DESPITE PANDEMIC UNIQUE INNOVATION PLATFORMS AND INFRASTRUCTURE … Continue reading →

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ACRP blog

FEBRUARY 14, 2024

Food and Drug Administration (FDA) released its Draft Guidance on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. What better time than at the precipice of a new year to check in on this crucial topic and wonder aloud if our collective perseverance is leading to progress.

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XTalks

AUGUST 21, 2023

That’s why Tebra started The Intake and why we are excited to share it with the healthcare community,” said Kevin Marasco, chief marketing officer at Tebra, in the company’s news release. “We We recognize how challenging it is to source unbiased reporting, interviews and news to help better run a medical practice.

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BioTech 365

FEBRUARY 14, 2021

EQS Group-News: Rapid Nutrition PLC / Key word(s): Annual Results 15.02.2021 / 06:00 Rapid Nutrition Guidance Update with Notable 2020 Year-End Results London, Feb. 15, 2021 – Rapid Nutrition PLC (SW: RAP, OTCQB: RPNRF), a natural wellness company focused on … Continue reading →

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ACRP blog

JULY 26, 2022

The good news for those with a touch of phobia where numbers are concerned? “It The bad news? ICH E9 provides guidance on the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It doesn’t have to be too complicated,” Frestedt says.

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BioTech 365

JANUARY 21, 2021

DGAP-News: aap Implantate AG / Key word(s): Preliminary Results/Forecast 21.01.2021 / 17:57 The issuer is solely responsible for the content of this announcement. million in a COVID-19-driven FY/2020 in upper half of guidance of EUR … Continue reading → – Sales of EUR 9.3

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Pharmaceutical Technology

NOVEMBER 20, 2022

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. NICE’s technology appraisals calculate appropriate costs for drugs using the incremental cost-effectiveness ratio (ICER).

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FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What are nitrosamines? Seek, and ye shall find, so FDA hopes. In addition to the FDA’s efforts, agencies in the E.U.,

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BioTech 365

AUGUST 30, 2020

EQS Group-News: Rapid Nutrition PLC / Key word(s): Annual Results 30.08.2020 / 17:30 Rapid Nutrition Delivers Strong 2020 Results During Global Pandemic Trading Update and Financial Guidance London, via NEWMEDIAWIRE — Rapid Nutrition PLC (SW:RAP, OTCQB:RPNRF), a natural wellness company … Continue reading →

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XTalks

MARCH 15, 2024

In a news release , Lilly announced it, “selected Amazon Pharmacy as a dispensing pharmacy option, allowing patients to receive fast, free delivery of medications and 24/7 access to clinical pharmacists.”

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Drug Discovery World

DECEMBER 8, 2023

News round-up for 4-8 December by DDW Digital Content Editor Diana Spencer.

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The Pharma Data

OCTOBER 22, 2020

health officials released new guidance on Wednesday that redefines who is considered a “close contact” of an infected individual. More News Resources. Professional. CDC Broadens Definition of ‘Close Contact’ in Tracing COVID-19 Infections. THURSDAY, Oct. The Washington Post Article More Information.

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