Drugs and Marketing - Clinical Research Informer

SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 14, 2024

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs

Drugs Clinical Trials Clinical Trials Branding

Lilly market value soars on higher sales, obesity drug potential

Bio Pharma Dive

AUGUST 8, 2023

The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.

Marketing

Marketing Sales Drugs

Why DTC isn’t, and is, marketing

World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. However, DTC marketing is different, much different. So what’s the opportunity for DTC marketers?

Marketing

Marketing Production Drugs Doctors

Pfizer to pull sickle cell drug from market, shut down trials

Bio Pharma Dive

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

Trials

Trials Drugs Marketing

Osteoporosis market expected to reach $17.9bn across 7MM by 2033

Pharmaceutical Technology

JUNE 24, 2024

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% The osteoporosis market is expected to grow at a compound annual growth rate of 5.4%

Marketing

Marketing Drugs

EQRx builds case for cancer drug it hopes can disrupt market

Bio Pharma Dive

JANUARY 19, 2022

Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.

Drugs

Drugs Marketing

Sanofi takes a chance on Provention’s diabetes drug with marketing deal

Bio Pharma Dive

OCTOBER 6, 2022

The pharma will invest in the biotech and co-promote its drug teplizumab if the FDA OKs the medicine as a first-of-its-kind diabetes treatment.

Drugs

Drugs Marketing Medicine

On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Bio Pharma Dive

NOVEMBER 11, 2024

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

Drugs

Drugs Marketing

Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bio Pharma Dive

NOVEMBER 14, 2024

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

Regulation

Regulation Drugs Marketing

Is biotech facing a long bear market?

Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7.

Marketing

Marketing Gene Therapy Manufacturing Pharma Companies

A biotech wins the first FDA drug approval in a rare type of eye cancer

Bio Pharma Dive

JANUARY 26, 2022

based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S.

Drugs

Drugs Marketing

Amgen shares soar as executives outline obesity drug push

Bio Pharma Dive

MAY 3, 2024

The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

Drugs

Drugs Marketing

Lilly looks to speed FDA review of new diabetes drug in obesity

Bio Pharma Dive

OCTOBER 6, 2022

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.

Drugs

Drugs Trials Marketing

Seagen, Astellas win expanded FDA approval for bladder cancer drug

Bio Pharma Dive

APRIL 4, 2023

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

FDA Approval

FDA Approval Drugs Marketing

Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

DECEMBER 5, 2023

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

Drugs

Drugs Marketing

Top 20 biopharmas’ market cap up 4.3% in Q2 2024 as GLP-1 drug innovators hold top spots

Pharmaceutical Technology

AUGUST 20, 2024

The top 20 biopharmaceutical companies demonstrated resilience during the second quarter (Q2) of 2024 as global markets and investor optimism improved with anticipation of a potential interest rate cut from the US Federal Reserve.

Marketing

Marketing Drugs

More federal regulators investigating Biogen's Alzheimer's drug

Bio Pharma Dive

FEBRUARY 4, 2022

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.

Regulation

Regulation Drugs Marketing

Sionna revives AbbVie’s cystic fibrosis drugs, eyeing a shot at Vertex

Bio Pharma Dive

JULY 16, 2024

The well-funded startup says drugs AbbVie abandoned last year could form a combination regimen with “superior efficacy” to Vertex’s market-leading medicines.

Drugs

Drugs Medicine Marketing

Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Pharmaceutical Technology

SEPTEMBER 1, 2023

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

Drugs

Drugs Marketing

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Bio Pharma Dive

SEPTEMBER 21, 2021

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

FDA Approval

FDA Approval Drugs Antibody Medicine

Flagship’s Lovisa Afzelius on creating a successful biotech and a ‘very different’ startup market

Bio Pharma Dive

DECEMBER 13, 2022

Even with a shaky market for drug startups, the Apriori CEO and Alltrna cofounder said Flagship will continue its approach of betting on ambitious, and unproven, science.

Marketing

Marketing Drugs

GSK to pull blood cancer drug from US market after study failure

Bio Pharma Dive

NOVEMBER 22, 2022

The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.

Marketing

Marketing Drugs

FDA approves Sanofi’s long-lasting hemophilia drug

Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

FDA Approval

FDA Approval Drugs Protein Marketing

FDA opens case to withdraw controversial drug for preterm births

Bio Pharma Dive

OCTOBER 17, 2022

Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market.

Drugs

Drugs Marketing

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

Bio Pharma Dive

DECEMBER 5, 2022

The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

Sales

Sales Drugs Marketing

GSK cancer drug Blenrep gets surprise trial win

Bio Pharma Dive

NOVEMBER 27, 2023

drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch. One year after the U.K.

Drugs

Drugs Trials Marketing

3 biotech executives on the year ahead: deals, drug pricing and the down market

Bio Pharma Dive

JANUARY 19, 2023

“What we’re experiencing now is the aftershock of the party that went on for the last three years,” said Ovid CEO Jeremy Levin in a BioPharma Dive panel that included former Sage head Jeff Jonas and biotech entrepreneur Greg Verdine.

Marketing

Marketing Drugs

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

JULY 26, 2022

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Marketing

Marketing Gene Branding Clinical Development

Lotus Pharmaceuticals and Teraju Pharma link for marketing in Malaysia

Pharmaceutical Technology

JUNE 12, 2023

Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure.

Marketing

Marketing Production Branding Manufacturing

Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. Specialty drugs are most used to treat different cancers, rheumatoid arthritis, and multiple sclerosis. The only way forward for generics producers.

Drugs

Drugs Manufacturing Production Marketing

Takeda wins FDA approval for targeted lung cancer drug

Bio Pharma Dive

SEPTEMBER 16, 2021

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.

FDA Approval

FDA Approval Drugs Gene Marketing

FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

Bio Pharma Dive

DECEMBER 20, 2021

The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.

Drugs

Drugs Regulation Marketing

Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

Drugs

Drugs Cosmetics Production FDA Approval

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.

Drugs

Drugs FDA Approval Clinical Trials Clinical Trials

FDA generic drug approvals rose in 2023 in bid for improved access

Pharmaceutical Technology

FEBRUARY 23, 2024

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

Generic Drugs

Generic Drugs Drugs Marketing

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

APRIL 3, 2023

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience.

Marketing

Marketing Medicine Packaging Packaging

Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

DECEMBER 22, 2022

The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American. Fentanyl was first synthesised in 1959 and introduced to markets in the 1960s as a pain relief drug.

Drugs

Drugs Manufacturing Production Marketing

Viking’s weight loss drug enters an already crowded arena

Pharmaceutical Technology

MARCH 29, 2023

In that trial, the drug demonstrated positive signs of clinical activity – all patients receiving VK2735 reported a loss in mean body weight. According to Sara Reci, analyst at GlobalData, many late-stage pipeline products for obesity emulate what is currently on the market, and employ the GLP-1 mechanism of action.

Drugs

Drugs In-Vivo Marketing Trials

Novartis sales of Zolgensma gene therapy slow as market shifts

Bio Pharma Dive

OCTOBER 25, 2022

Treatment is now mostly of infants newly diagnosed with spinal muscular atrophy, as many of those previously eligible either already received Zolgensma or other drugs from Biogen and Roche.

Gene Therapy

Gene Therapy Sales Gene Marketing

US plans shift to private market sales of COVID-19 vaccines, drugs

Bio Pharma Dive

AUGUST 17, 2022

The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their shots and therapeutics.

Sales

Sales Marketing Vaccine Vaccination

Troubling data leads a biotech to pull its prized drug from market and FDA review

Bio Pharma Dive

APRIL 18, 2022

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

Clinical Trials

Clinical Trials Clinical Trials Marketing Medicine

CVS launches new venture in biosimilar drug experiment

Bio Pharma Dive

AUGUST 24, 2023

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

Drugs

Drugs Manufacturing Marketing

Private biotech M&A surges amid difficult IPO market

Bio Pharma Dive

JULY 22, 2024

Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, but not yet public, drug startups.

Marketing

Marketing Drugs

FDA approves Gomekli as first neurofibromatosis drug for adults

Pharmaceutical Technology

FEBRUARY 12, 2025

Merck acquisition target SpringWorks will go toe-to-toe with AstraZeneca in the US neurofibromatosis market.

FDA Approval

FDA Approval Drugs Marketing

SEC recommends approval for MSN Laboratories’ sleep disorder drug

Lilly market value soars on higher sales, obesity drug potential

Trending Sources

Why DTC isn’t, and is, marketing

Pfizer to pull sickle cell drug from market, shut down trials

Osteoporosis market expected to reach $17.9bn across 7MM by 2033

EQRx builds case for cancer drug it hopes can disrupt market

Sanofi takes a chance on Provention’s diabetes drug with marketing deal

On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Eisai wins over European regulators on Alzheimer’s drug Leqembi

Is biotech facing a long bear market?

A biotech wins the first FDA drug approval in a rare type of eye cancer

Amgen shares soar as executives outline obesity drug push

Lilly looks to speed FDA review of new diabetes drug in obesity

Seagen, Astellas win expanded FDA approval for bladder cancer drug

Q&A: Tackling the rise of fake anti-obesity drugs on the market

Top 20 biopharmas’ market cap up 4.3% in Q2 2024 as GLP-1 drug innovators hold top spots

More federal regulators investigating Biogen's Alzheimer's drug

Sionna revives AbbVie’s cystic fibrosis drugs, eyeing a shot at Vertex

Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Flagship’s Lovisa Afzelius on creating a successful biotech and a ‘very different’ startup market

GSK to pull blood cancer drug from US market after study failure

FDA approves Sanofi’s long-lasting hemophilia drug

FDA opens case to withdraw controversial drug for preterm births

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

GSK cancer drug Blenrep gets surprise trial win

3 biotech executives on the year ahead: deals, drug pricing and the down market

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Lotus Pharmaceuticals and Teraju Pharma link for marketing in Malaysia

Do generics producers have what it takes to tackle complex and specialty drugs?

Takeda wins FDA approval for targeted lung cancer drug

FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

Novo’s obesity drug has serious warnings and barriers to overcome

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

FDA generic drug approvals rose in 2023 in bid for improved access

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Fentanyl: a horrifyingly disruptive drug

Viking’s weight loss drug enters an already crowded arena

Novartis sales of Zolgensma gene therapy slow as market shifts

US plans shift to private market sales of COVID-19 vaccines, drugs

Troubling data leads a biotech to pull its prized drug from market and FDA review

CVS launches new venture in biosimilar drug experiment

Private biotech M&A surges amid difficult IPO market

FDA approves Gomekli as first neurofibromatosis drug for adults

Stay Connected