Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

Marketing 130

Marketing Sales Manufacturing Drugs 130

pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. Engagement channels. Joanna Carlish.

Regulation 97

Regulation Marketing Sales Branding 97

Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. The EMA had provided a positive opinion for this marketing authorization back in July.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

Marketing 52

Marketing Compliance Packaging Packaging 52

Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. These meetings will be held to help drug developers prepare for their MAAs through an assessment of development plans amongst other things.

Development 130

Development Drugs Medicine Production 130

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

Marketing 40

Marketing Compliance Packaging Packaging 40

FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59

Drugs Licensing Licensing Production 59

XTalks

FEBRUARY 13, 2024

However, the line between enticing marketing and misleading information can sometimes blur, leading to controversies and legal actions. This dynamic has propelled misleading advertisement lawsuits into the spotlight, with several high-profile cases raising questions about the integrity of food marketing and its impact on consumer trust.

Marketing 59

Marketing Containment Production Packaging 59

Pharmaceutical Technology

JULY 29, 2022

Once new vaccines for the Omicron variant are approved, they will partly make up for the waning interest in older Covid boosters in developed markets. This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

pharmaphorum

DECEMBER 10, 2021

Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe, but has now withdrawn its EU marketing application. Shares in Intercept slipped around 15% after it announced the news.

Drugs 98

Drugs Sales Marketing Packaging 98

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The FDA governs the drug and biologic approval process in the United States, while the EMA serves the European Union (EU) plus Iceland, Norway, and Liechtenstein.

Production 230

Production Packaging Packaging Marketing 230

pharmaphorum

AUGUST 20, 2020

US biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was described by analysts as a “major setback” when the FDA rejected its gene therapy for haemophilia A. The post BioMarin files achondroplasia drug after rejection for haemophilia therapy appeared first on.

Gene Therapy 64

Gene Therapy Drugs Regulation Gene 64

Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. These distinctions are important as they determine the regulatory burden required to market a product in Canada.

Production 52

Production Cosmetics Regulation Branding 52

Pharmaceutical Technology

MARCH 10, 2023

The pharmaceutical freeze-drying systems market is expected to be driven by the integration of smarter technologies in lyophilisation methods such as electron microscopy, biochemistry, and advancement in surgeries. The process eliminates the disadvantages of conventional drying methods or freezing.

Manufacturing 147

Manufacturing Production Containment Antibody 147

pharmaphorum

NOVEMBER 11, 2022

Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully.

Clinical Development 52

Clinical Development Marketing Regulation Packaging 52

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com. AUTHORIZED USE The U.S.

Marketing 75

Marketing Production Drugs Licensing 75

pharmaphorum

AUGUST 12, 2022

The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed. The conflict in Ukraine once again underscores how quickly the status quo can break down and lead to vital drug shortages that put public health in dire straits.

Manufacturing 59

Manufacturing Production Drugs Regulation 59

Drug Discovery World

SEPTEMBER 26, 2022

DDW Editor Reece Armstrong explores the rise of drug repurposing and the benefits and disadvantages it brings to drug discovery and development. . Drug repurposing, the act of finding new clinical targets for both approved and unapproved drugs, has emerged as a viable alternative to traditional drug discovery approaches. .

Drugs 52

Drugs Genome Genomics Clinical Trials 52

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

Camargo

JUNE 4, 2021

The FDA required that Heron Therapeutic conduct several post-marketing studies, including two nonclinical studies and multicenter studies of the pharmacokinetics, safety, and pharmacodynamic response of Zynrelef administered for postoperative analgesia in pediatric patients undergoing unilateral open inguinal herniorrhaphy (groin hernia).

Development 130

Development Production Drugs Marketing 130

XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal.

FDA Approval 98

FDA Approval Packaging Packaging Production 98

Camargo

JANUARY 12, 2022

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. prior to filing an Investigational New Drug [IND] application).

Production 169

Production Gene Therapy Packaging Packaging 169

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Jardiance brought in $2.06

Sales 52

Sales Insulin FDA Approval Drugs 52

FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

XTalks

JANUARY 11, 2021

The word “sustainable” often gets tossed around in the food and beverage industry, with companies making certain claims about their products to market themselves as the better option. From sustainably-grown fruits and vegetables to sustainably-sourced coffee beans — not to mention sustainable packaging — what does it all mean?

Production 52

Production Packaging Packaging Branding 52

Pharma in Brief

AUGUST 3, 2023

Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ). Unlike the draft guidance circulated for feedback, the definition now also explicitly excludes patients prescribed a drug by an HCP. Clinical trial recruitment.

Production 52

Production Drugs Manufacturing Clinical Trials 52

BioPharma Reporter

OCTOBER 12, 2021

Drug packaging and delivery system company, Gerresheimer, noted the prefillable syringes business is booming as it reported double digit organic revenue growth in Q3 2021.

Packaging 52

Packaging Packaging Drugs Regulation 52

pharmaphorum

APRIL 21, 2021

The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

Packaging 59

Packaging Packaging Sales Production 59

XTalks

DECEMBER 1, 2021

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases. Where the gadget will fit into the $19.5

Contamination 98

Contamination Packaging Packaging Regulation 98

XTalks

AUGUST 4, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. In this episode of the Xtalks Food Podcast, Sydney talks about the social media-based food scandal, from Pink Sauce’s ingredients to packaging and marketing.

Branding 52

Branding Sales Packaging Packaging 52

pharmaphorum

AUGUST 24, 2020

In the run up to the conference, Alan Franklin, CEO, ForwardVue Pharma is interviewed by SMi Group to discuss his presentation details, insights of the Ophthalmic market and his thoughts on the biggest growth area and key developments that have taken place in the last year. Ophthalmic Drugs Conference. 23 rd -24 th November 2020.

Drugs 52

Drugs Packaging Packaging Development 52

pharmaphorum

JANUARY 18, 2022

The global pre-filled syringes market was valued at $1139.6 Deep S Bhattacharya, Senior Scientist, Drug Product Development and Design, Pfizer. Assess the evolving regulatory landscape for pre-filled syringes and discuss approaches to work with regulators as guidance is updated. Who should Attend: Drug-delivery developers.

Drug Delivery 52

Drug Delivery Production Drug Delivery Systems Packaging 52

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###. 29 and Sep.

Contamination 52

Contamination Production Cosmetics Packaging 52